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DRUG:

AiRuiKa (camrelizumab)

i
Other names: INCSHR1210, SHR-1210, HR-301210, INCSHR-1210, SHR1210, HR301210, HR 301210, INCSHR 1210, SHR 1210
Company:
CG Invites, HLB Bio Group, Jiangsu Hengrui Pharma
Drug class:
PD1 inhibitor
Related drugs:
3d
Special entities of the head and neck region: cancers of the nasopharynx, (para)nasal cavities, salivary glands, and the thyroid gland : Post ASCO 2024 (PubMed, HNO)
In the treatment of locally advanced NPC, a randomized phase III study showed equivalence of induction (ICT) and adjuvant therapy (AT; NCT03306121). PD-1 inhibitors have become established in the palliative therapy of NPC in recent years and could now also play an increasing role in curation: the phase III study "Dipper" showed a significantly better 3‑year event-free survival in patients adjuvantly treated with camrelizumab versus placebo after IT and definitive platinum-containing chemoradiotherapy (dRCT; 89% vs. 80%; NCT03427827). The phase III study "Beacon" showed complete remission in 30.5% of patients after IT with gemcitabine/cisplatin and the PD‑1 inhibitor tislelizumab (three cycles), a rate almost twice as high as with gemcitabine/cisplatin alone (NCT05211232). Intensification of dRCT in NPC using EGFR and VEGF inhibitors appears promising (NCT04447326). Abstracts on salivary gland and nasal and sinus cancers emphasize the importance of targeted therapies. In anaplastic thyroid carcinoma, the combination of a PD‑1 inhibitor and a CTLA4 inhibitor showed a 50% response.
Review • Journal
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EGFR (Epidermal growth factor receptor)
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cisplatin • gemcitabine • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr)
3d
Neoadjuvant Camrelizumab with Palbociclib for Resectable Esophageal Squamous Cell Carcinomas (clinicaltrials.gov)
P1, N=6, Recruiting, West China Hospital | Trial primary completion date: Oct 2024 --> Oct 2025
Trial primary completion date
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Ibrance (palbociclib) • AiRuiKa (camrelizumab)
3d
Enrollment open
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carboplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • goserelin acetate
3d
Response to furmonertinib in a patient with non-small cell lung cancer harboring HER2 exon 21 insertion mutation: a case report. (PubMed, Front Oncol)
Firstly, we describe the patient's treatment history, including failed third-line combination treatments of systemic chemotherapy with bevacizumab or carrelizumab or anlotinib, primary lung tumor recurrence, bilateral lung metastases progression, and new brain metastatic lesion detection. Next, we detail the patient's fourth-line treatment with radiotherapy for brain metastases and two cycles of bevacizumab plus Abraxane and cisplatin, however, the disease progressed and relapsed...However, the patient died due to hypoproteinemia combined with severe pneumonia in December 2023. Furmonertinib may be effective for NSCLC patients with HER2 T8962A and L869R mutations and further studies are needed to confirm these results in prospective clinical trials.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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EGFR mutation • HER-2 mutation • HER-2 L869R
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Avastin (bevacizumab) • cisplatin • Focus V (anlotinib) • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Ivesa (firmonertinib)
8d
Single-arm clinical study on the treatment of locally advanced cervical cancer with camrelizumab combined with concurrent chemoradiotherapy (ChiCTR2400089150)
P=N/A, N=75, Not yet recruiting, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine; Shanghai First Maternity and Infant Hospital, Tongji University Sc
New trial • Metastases
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AiRuiKa (camrelizumab) • Kaitanni (cadonilimab)
8d
New P2 trial
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AiRuiKa (camrelizumab) • AiTan (rivoceranib)
10d
Trial completion • Combination therapy • Metastases
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PD-L1 (Programmed death ligand 1)
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AiRuiKa (camrelizumab) • AiTan (rivoceranib) • capecitabine • oxaliplatin
13d
Hepatic Arterial Infusion Combined With Lenvatinib and Camrelizumab for Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
P2, N=39, Completed, Nanfang Hospital, Southern Medical University | Recruiting --> Completed
Trial completion
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Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • oxaliplatin
13d
New P3 trial • Metastases
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cisplatin • AiRuiKa (camrelizumab)
13d
Enrollment open
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PD-L1 (Programmed death ligand 1)
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cisplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel
14d
Camrelizumab combined with gemcitabine and apatinib in treating advanced PD-L1-positive biliary tract cancers. (PubMed, Cancer Sci)
The most frequent grade 3 or 4 treatment-related adverse event was neutropenia (n = 4, 29%). The combination of camrelizumab, gemcitabine, and apatinib showed promising efficacy and acceptable safety in patients with advanced PD-L1-positive biliary tract cancer.
Journal • Metastases
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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gemcitabine • AiRuiKa (camrelizumab) • AiTan (rivoceranib)
14d
Nab-paclitaxel Plus PD-1 Inhibitor Versus Nab-paclitaxel As Second-line Treatment in Advanced Gastric Cancer (clinicaltrials.gov)
P2, N=58, Terminated, Huazhong University of Science and Technology | Trial completion date: Jun 2023 --> Nov 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2023 --> Nov 2023; slow recruitment forcing early suspension of screening and enrollment
Trial completion date • Trial termination • Trial primary completion date • Metastases
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AiRuiKa (camrelizumab) • albumin-bound paclitaxel
17d
New P3 trial
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cisplatin • gemcitabine • AiRuiKa (camrelizumab) • capecitabine • albumin-bound paclitaxel
17d
NACI: Pd-1 Antibody Combined Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer (clinicaltrials.gov)
P2, N=85, Active, not recruiting, Huazhong University of Science and Technology | Recruiting --> Active, not recruiting
Enrollment closed
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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cisplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel
19d
Impact of baseline body mass index on the long-term prognosis of advanced hepatocellular carcinoma treated with immunotherapy. (PubMed, World J Gastroenterol)
BMI is a long-term predictor of the efficacy of lenvatinib plus camrelizumab, and obese/overweight patients have a better prognosis.
Retrospective data • Journal • Metastases
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AFP (Alpha-fetoprotein)
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Lenvima (lenvatinib) • AiRuiKa (camrelizumab)
19d
NACI-CERV-003: Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC (clinicaltrials.gov)
P2/3, N=440, Recruiting, Tongji Hospital | Not yet recruiting --> Recruiting
Enrollment open • Surgery • Metastases
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cisplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel
19d
NACI-CERV-002: Neoadjuvant Immunochemotherapy in PD-L1-negative LACC (clinicaltrials.gov)
P2, N=40, Recruiting, Tongji Hospital | Not yet recruiting --> Recruiting | Initiation date: Mar 2024 --> Sep 2024
Enrollment open • Trial initiation date • Metastases
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cisplatin • paclitaxel • AiRuiKa (camrelizumab)
26d
New P1 trial
|
Ibrance (palbociclib) • AiRuiKa (camrelizumab)
28d
CD34 as a potential prognostic indicator for camrelizumab response in advanced non-small-cell lung cancer: insights from digital spatial profiling. (PubMed, Ther Adv Med Oncol)
Our findings identify CD34 as a novel spatial biomarker for anti-PD-1 therapy efficacy, potentially guiding the selection of aNSCLC patients who are more likely to benefit from ICI treatment. ChiCTR2000040416.
Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
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CD34 (CD34 molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CD68 (CD68 Molecule)
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AiRuiKa (camrelizumab)
1m
Combined Treatment of Camrelizumab and Bevacizumab for Adult Patients with Recurrent Glioblastoma (GBM) (clinicaltrials.gov)
P2, N=3, Terminated, Beijing Sanbo Brain Hospital | N=94 --> 3 | Suspended --> Terminated; Lack of funds
Enrollment change • Trial termination
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
|
IDH wild-type
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Avastin (bevacizumab) • AiRuiKa (camrelizumab)
1m
Camrelizumab for Patients with Recurrent Primary Central Nervous System Lymphoma (PCNSL) (clinicaltrials.gov)
P2, N=21, Recruiting, Beijing Sanbo Brain Hospital | Trial primary completion date: Dec 2023 --> Dec 2024
Trial primary completion date
|
AiRuiKa (camrelizumab)
1m
SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma (clinicaltrials.gov)
P2, N=34, Suspended, Zhejiang Cancer Hospital | Recruiting --> Suspended
Trial suspension • Surgery
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AiRuiKa (camrelizumab) • Sulanda (surufatinib)
1m
Combination kinase inhibitors and immunotherapy for unresectable anaplastic thyroid carcinoma: A retrospective single-center study. (PubMed, Oral Oncol)
Combination kinase inhibitors with immunotherapy as first-line therapy are safe and effective for the treatment of unresectable ATC, especially with BRAF V600E mutation.
Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
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BRAF (B-raf proto-oncogene)
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BRAF V600E
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Keytruda (pembrolizumab) • Mekinist (trametinib) • Tafinlar (dabrafenib) • Focus V (anlotinib) • Tyvyt (sintilimab) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab)
1m
New trial
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carboplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • cyclophosphamide • epirubicin • Ariely (adebrelimab)
1m
New P2 trial
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AiRuiKa (camrelizumab) • AiTan (rivoceranib)
1m
A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC (clinicaltrials.gov)
P2, N=60, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
New P2 trial
|
AiRuiKa (camrelizumab) • albumin-bound paclitaxel
1m
New trial • Combination therapy • Metastases
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5-fluorouracil • Tyvyt (sintilimab) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr)
1m
New trial • Combination therapy • Checkpoint inhibition • Metastases
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Keytruda (pembrolizumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • sorafenib • 5-fluorouracil • Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • AiTan (rivoceranib) • Zepsun (donafenib)
1m
New trial • Combination therapy • Metastases
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5-fluorouracil • Tyvyt (sintilimab) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr)
2ms
Enrollment change
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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ER positive • HR positive • HER-2 amplification • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
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Avastin (bevacizumab) • sorafenib • everolimus • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • capecitabine • albumin-bound paclitaxel • fulvestrant • exemestane • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • SHR-A2102 • SHR-A1921 • SHR-A2009
2ms
New trial
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Tyvyt (sintilimab) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr)
2ms
[18F]AlF-NOTA-FAPI-04 PET/CT for Predicting Pathologic Response of Resectable Esophageal Squamous Cell Carcinoma to Neoadjuvant Camrelizumab and Chemotherapy: A Phase II Clinical Trial. (PubMed, J Nucl Med)
Changes in SUVmax (AUC, 0.81; P = 0.0116), SUVpeak (AUC, 0.82; P = 0.0097), SUVmean (AUC, 0.81; P = 0.0116), and TBRmean (AUC, 0.74; P = 0.0489) also were significant predictors of the pathologic response to nCC, with sensitivities and specificities in similar ranges. 18F-FAPI PET/CT parameters after treatment and their changes from baseline can predict the pathologic response to nCC in LA-ESCC participants.
P2 data • Journal • PD(L)-1 Biomarker
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FAP (Fibroblast activation protein, alpha)
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FAP expression
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AiRuiKa (camrelizumab)
2ms
New P2 trial
|
gemcitabine • AiRuiKa (camrelizumab)
2ms
PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allo-HSCT (clinicaltrials.gov)
P=N/A, N=43, Recruiting, The First Affiliated Hospital of Soochow University | Trial primary completion date: Jul 2024 --> Jul 2025
Trial primary completion date
|
AiRuiKa (camrelizumab) • azacitidine
2ms
New P2 trial
|
AiRuiKa (camrelizumab) • AiTan (rivoceranib) • oxaliplatin
2ms
Efficacy and safety of camrelizumab combined with chemotherapy in the treatment of advanced biliary malignancy and associations between peripheral blood lymphocyte subsets and clinical outcomes. (PubMed, Clin Transl Oncol)
Camrelizumab combining chemotherapy significantly prolonged the mPFS and mOS of advanced BTC patients. Immunotherapy may improve the immune status of advanced patients, and immunotherapy efficacy might be predicted based on the peripheral blood lymphocyte subsets.
Clinical data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
AiRuiKa (camrelizumab)
2ms
New trial
|
PD-L1 (Programmed death ligand 1)
|
AiRuiKa (camrelizumab)
2ms
Camrelizumab combined with chemotherapy for stage IV pulmonary sarcomatoid cancer with pancreatic metastases. (PubMed, Respir Med Case Rep)
Camrelizumab and chemotherapy were administered, and the metastasis disappeared. Immunotherapy combined with platinum-based chemotherapy is effective in treating PSC with pancreatic metastases.
Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
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KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53)
|
TP53 mutation • KRAS mutation • TP53 mutation + KRAS mutation • KRAS mutation + TP53 mutation
|
AiRuiKa (camrelizumab)
2ms
New trial
|
AiRuiKa (camrelizumab) • AiTan (rivoceranib)
2ms
New trial • Metastases
|
AiRuiKa (camrelizumab) • albumin-bound paclitaxel • Epidaza (chidamide) • Teysuno (gimeracil/oteracil/tegafur)
2ms
New P4 trial • Metastases
|
AiRuiKa (camrelizumab) • AiTan (rivoceranib)