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    DRUG:

    AiRuiKa (camrelizumab)

    i
    Other names: INCSHR1210, SHR-1210, HR-301210, INCSHR-1210, SHR1210
    Company:
    CG Invites, HLB Bio Group, Jiangsu Hengrui Pharma
    Drug class:
    PD1 inhibitor
    Related drugs:
    3d
    Comprehensive multi-omics analysis of resectable locally advanced gastric cancer: Assessing response to neoadjuvant camrelizumab and chemotherapy in a single-center, open-label, single-arm phase II trial. (PubMed, Clin Transl Med)
    The findings suggest the combination of PD-1-inhibitor and mFOLFOX6 showed efficacy and acceptable toxicity for locally advanced GC. Extended follow-up is required to determine the duration of the response. This study lays essential groundwork for developing precise neoadjuvant regimens.
    P2 data • Clinical Trial,Phase II • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • MIF (Macrophage Migration Inhibitory Factor) • CCKBR (Cholecystokinin B Receptor)
    |
    HER-2 positive • HER-2 mutation • CTNNB1 mutation
    |
    5-fluorouracil • AiRuiKa (camrelizumab) • oxaliplatin • leucovorin calcium
    3d
    Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=83, Recruiting, Chinese PLA General Hospital | Trial primary completion date: Feb 2024 --> Jul 2024
    Trial primary completion date • Metastases
    |
    gemcitabine • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Sulanda (surufatinib) • Teysuno (gimeracil/oteracil/tegafur)
    4d
    ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Peking Union Medical College Hospital
    New P2 trial • Checkpoint inhibition • IO biomarker • Metastases
    |
    Keytruda (pembrolizumab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab)
    7d
    Enhancing survival outcomes in stage Ⅲ gastric/esophagogastric junction cancer: a retrospective study of immune checkpoint inhibitors and adjuvant chemotherapy based on real-world data (PubMed, Zhonghua Wei Chang Wai Ke Za Zhi)
    Of them, 85 received pembrolizumab, 10 received sintilimab, 8 received tislelizumab, 4 received camrelizumab, 2 received toripalimab, and 1 received pabocizumab. The adjuvant chemotherapy regimens used among the chemotherapy alone group includes SOX regimen (132 cases), XELOX (102 cases), S-1 monotherapy (44 cases), and other regimens (15 cases)...Subgroup analysis showed that stage IIIC (HR=0.416, 95%CI: 0.184~0.940), aged ≥60 years (HR=0.336, 95%CI: 0.121~0.934) and extranodal invasion (HR=0.378, 95%CI: 0.170~0.839) were associated with benefit from the combined immune adjuvant chemotherapy, while no association was observed for MMR, HER-2 or EBER status. Stage III gastric/esophagogastric junction cancer patients may benefite from postoperative immune checkpoint inhibitor combined with adjuvant chemotherapy in real-world settings.
    Retrospective data • Journal • Checkpoint inhibition • Real-world evidence • Real-world
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-1 (Programmed cell death 1)
    |
    HER-2 positive • MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Tyvyt (sintilimab) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab) • capecitabine • oxaliplatin
    7d
    Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response (clinicaltrials.gov)
    P3, N=593, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
    Enrollment open • Head-to-Head
    |
    cisplatin • gemcitabine • AiRuiKa (camrelizumab) • capecitabine
    11d
    The emerging therapies are reshaping the first-line treatment for advanced hepatocellular carcinoma: a systematic review and network meta-analysis. (PubMed, Therap Adv Gastroenterol)
    In the whole-population network meta-analysis, the newly first-line tremelimumab plus durvalumab (Tre + Du) was found to be comparable with atezolizumab plus bevacizumab (Atezo + Beva) in providing the best overall survival (OS) benefit [hazard ratio (HR) 1.35, 95% confidence interval (CI): 0.93-1.92]. Concerning OS benefits, sintilimab plus bevacizumab biosimilar (Sint + Beva), camrelizumab plus rivoceranib (Camre + Rivo), and lenvatinib plus pembrolizumab (Lenva + Pemb) appear to exhibit similar effects to Tre + Du and Atezo + Beva...With lower incidence rates of treatment-related adverse events and non-inferior efficacy compared to sorafenib, ICI monotherapies should be prioritized as a first-line treatment approach for patients who are not suitable candidates for ICI-combined therapies. PROSPERO, CRD42022288172.
    Clinical • Retrospective data • Review • Journal • Metastases
    |
    AFP (Alpha-fetoprotein)
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • sorafenib • Tyvyt (sintilimab) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Imjudo (tremelimumab)
    11d
    Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC (clinicaltrials.gov)
    P2, N=111, Recruiting, Peking University Cancer Hospital & Institute | Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Jan 2024
    Enrollment open • Trial initiation date
    |
    Avastin (bevacizumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • adebrelimab (SHR-1316)
    14d
    Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=43, Recruiting, Beijing Tongren Hospital
    New P1/2 trial • Metastases
    |
    AiRuiKa (camrelizumab) • Oncaspar liquid (pegaspargase) • Itari (linperlisib) • dexamethasone injection
    14d
    Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping. (clinicaltrials.gov)
    P=N/A, N=234, Completed, Fujian Medical University
    New trial • Real-world evidence • Real-world
    |
    AiRuiKa (camrelizumab) • AiTan (rivoceranib)
    16d
    A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=57, Recruiting, Fujian Medical University | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    AiRuiKa (camrelizumab) • AiTan (rivoceranib) • oxaliplatin
    17d
    A Study of Camrelizumab in Combination With Chemotherapy Regimen Comparative Chemotherapy Regimen for Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P3, N=1, Terminated, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=104 --> 1 | Not yet recruiting --> Terminated; Sponsor R & D Strategy Adjustment]
    Enrollment change • Trial termination • Combination therapy • Metastases
    |
    gemcitabine • AiRuiKa (camrelizumab) • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate
    21d
    A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=57, Not yet recruiting, Fujian Medical University
    New P2 trial • Metastases
    |
    AiRuiKa (camrelizumab) • AiTan (rivoceranib) • oxaliplatin
    21d
    A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2/3, N=482, Not yet recruiting, Hutchmed
    New P2/3 trial • Metastases
    |
    gemcitabine • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Sulanda (surufatinib)
    22d
    Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC (clinicaltrials.gov)
    P2, N=111, Not yet recruiting, Peking University Cancer Hospital & Institute
    New P2 trial
    |
    Avastin (bevacizumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • adebrelimab (SHR-1316)
    24d
    PACIFIC-NPC: PD-1 Antibody Versus Best Supportive Care After Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=450, Active, not recruiting, Sun Yat-sen University | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    AiRuiKa (camrelizumab)
    25d
    NITDC: Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer (clinicaltrials.gov)
    P=N/A, N=18, Recruiting, Peking Union Medical College Hospital | Not yet recruiting --> Recruiting
    Enrollment open • Mismatch repair
    |
    AiRuiKa (camrelizumab)
    29d
    Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Sichuan University
    New P1 trial
    |
    AiRuiKa (camrelizumab) • capecitabine
    30d
    NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study (clinicaltrials.gov)
    P2, N=40, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P2 trial
    |
    5-fluorouracil • AiRuiKa (camrelizumab) • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    30d
    CPOG-007-A: SHR- 1210 Combined With Paclitaxel (Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P=N/A, N=40, Completed, RenJi Hospital | Unknown status --> Completed | N=20 --> 40 | Trial completion date: Jul 2022 --> May 2023
    Trial completion • Enrollment change • Trial completion date • Metastases
    |
    gemcitabine • paclitaxel • AiRuiKa (camrelizumab)
    1m
    A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P3, N=401, Recruiting, RenJi Hospital | Not yet recruiting --> Recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Enrollment open • Trial completion date • Trial primary completion date • Metastases
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    gemcitabine • paclitaxel • AiRuiKa (camrelizumab) • albumin-bound paclitaxel
    1m
    Thalidomide Prevention or Treatment of Camrelizumab-induced Reactive Cutaneous Capillary Endothelial Proliferation (RCCEP) (clinicaltrials.gov)
    P2, N=132, Recruiting, Henan Cancer Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • carboplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • thalidomide
    1m
    HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma (clinicaltrials.gov)
    P=N/A, N=300, Recruiting, Sun Yat-sen University
    New trial • Real-world evidence • Real-world
    |
    5-fluorouracil • Tyvyt (sintilimab) • Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab) • oxaliplatin
    1m
    A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P3, N=441, Completed, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression • PGR expression
    |
    AiRuiKa (camrelizumab)
    1m
    PTCA199-8: Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Fudan University | Initiation date: Jan 2024 --> Dec 2024
    Trial initiation date • Oncolytic virus • Metastases
    |
    AiRuiKa (camrelizumab) • Oncorine (recombinant human adenovirus type 5)
    1m
    PD-1 Combined With Adjuvant Chemotherapy and Antivascular Therapy Versus Chemotherapy Alone in Patients With Operable Triple-negative Breast Cancer (clinicaltrials.gov)
    P3, N=606, Recruiting, Fudan University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    paclitaxel • AiRuiKa (camrelizumab) • cyclophosphamide • epirubicin
    1m
    Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P=N/A, N=240, Recruiting, Sun Yat-sen University
    New trial • Real-world evidence • Real-world • Metastases
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • 5-fluorouracil • Tyvyt (sintilimab) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab) • oxaliplatin • epirubicin
    2ms
    PD-L1 mRNA derived from tumor-educated platelets as a potential immunotherapy biomarker in non-small cell lung cancer. (PubMed, Transl Lung Cancer Res)
    The patients were enrolled in clinical trials for immune checkpoint inhibitors (ICIs), including nivolumab, pembrolizumab, atezolizumab, durvalumab, tremelimumab, and camrelizumab. For the patients who were treated with immunotherapy alone (n=64), a similar PFS advantage was observed in the high PD-L1 group (2.8 vs. 8.0 months, P=0.002). This article presented the first data on TEP-derived PD-L1 mRNA in advanced NSCLC patients following immunotherapy and showed the potential advantage of using it as the surrogate biomarker for predicting the PFS and overall survival of patients following immunotherapy.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR wild-type • PD-L1-L
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • AiRuiKa (camrelizumab) • Imjudo (tremelimumab)
    2ms
    Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients (clinicaltrials.gov)
    P2, N=49, Recruiting, Hubei Cancer Hospital | Not yet recruiting --> Recruiting | Initiation date: Sep 2023 --> Feb 2024
    Enrollment open • Trial initiation date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • PD-1 (Programmed cell death 1)
    |
    Keytruda (pembrolizumab) • paclitaxel • Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab)
    2ms
    Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy (clinicaltrials.gov)
    P3, N=375, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New P3 trial
    |
    AiRuiKa (camrelizumab) • capecitabine
    2ms
    A Study to Evaluate SHR-1210 in Subjects With Advanced HCC (clinicaltrials.gov)
    P2, N=220, Completed, Jiangsu HengRui Medicine Co., Ltd. | Unknown status --> Completed
    Trial completion • Metastases
    |
    AiRuiKa (camrelizumab)
    2ms
    Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab (clinicaltrials.gov)
    P2, N=48, Not yet recruiting, Harbin Medical University
    New P2 trial • Metastases
    |
    AiRuiKa (camrelizumab) • capecitabine • oxaliplatin
    2ms
    Remodeling the tumor-immune microenvironment by anti-CTLA4 blockade enhanced subsequent anti-PD-1 efficacy in advanced nasopharyngeal carcinoma. (PubMed, NPJ Precis Oncol)
    We retrospectively analysis 2 phase I trial of ipilimumab and camrelizumab in Chinese R/M NPC patients. This study proposes that sequential therapy can potentially enhance treatment efficacy in chemotherapy-resistant NPC patients and provides insights into how preexisting anti-CTLA4 blockade can influence subsequent anti-PD-1 efficacy by remodeling the TME. Additionally, our results highlight the need for therapeutic strategies targeting naïve/memory B cells.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-L2 (Programmed Cell Death 1 Ligand 2)
    |
    PD-L1 expression • PD-L2 expression
    |
    Yervoy (ipilimumab) • AiRuiKa (camrelizumab)
    2ms
    Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P=N/A, N=600, Completed, Sun Yat-sen University | Trial completion date: Jul 2022 --> Jul 2023
    Trial completion date • Metastases
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tyvyt (sintilimab) • Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab)
    2ms
    Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC (clinicaltrials.gov)
    P2, N=30, Recruiting, Shandong Cancer Hospital and Institute | Initiation date: Jun 2023 --> Dec 2022
    Trial initiation date
    |
    cisplatin • carboplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel
    2ms
    Neoadjuvant Immunochemotherapy in PD-L1-negative LACC (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Tongji Hospital
    New P2 trial
    |
    cisplatin • paclitaxel • AiRuiKa (camrelizumab)
    2ms
    Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Tongji Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel
    2ms
    Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC (clinicaltrials.gov)
    P2/3, N=440, Not yet recruiting, Tongji Hospital
    New P2/3 trial
    |
    cisplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel
    2ms
    Preoperative single-dose camrelizumab and/or microwave ablation in women with early-stage breast cancer: A window-of-opportunity trial. (PubMed, Med)
    Camrelizumab combined with MWA was feasible for early-stage breast cancer. Peripheral CD8+ T cells were activated after combination therapy, dependent on monocytes with activated MHC class I pathways.
    Journal
    |
    CD8 (cluster of differentiation 8)
    |
    AiRuiKa (camrelizumab)
    2ms
    A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Meng Chao Hepatobiliary Hospital of Fujian Medical University
    New P2 trial
    |
    AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Stivarga (regorafenib) • Kaitanni (cadonilimab)
    2ms
    SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, Henan Cancer Hospital | Unknown status --> Active, not recruiting | Trial completion date: Jun 2022 --> Dec 2026 | Trial primary completion date: Dec 2020 --> Jan 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    Herceptin (trastuzumab) • AiRuiKa (camrelizumab) • capecitabine • oxaliplatin
    2ms
    Immune-related thyroid dysfunction in patients with non-small cell lung cancer. (PubMed, J Thorac Dis)
    The ATAs, TPOAb, and abnormal thyroid ultrasonographic findings (irregular echo patterns and diffuse changes) are potential biomarkers of irTDs. Patients with NSCLC treated with ICIs (pembrolizumab, sintilimab, atezolizumab, and camrelizumab) who developed irTDs had no advantage in terms of clinical outcomes compared to euthyroid patients.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    IL6 (Interleukin 6)
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • Tyvyt (sintilimab) • AiRuiKa (camrelizumab)
    2ms
    A Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P4, N=104, Not yet recruiting, Tongji University
    New P4 trial
    |
    cisplatin • carboplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • thalidomide