Tyvyt (sintilimab)

This is a single-arm, phase II trial (NCT04026841) using Simon's optimal two-stage design, of which 4 doses of sintilimab (200 mg per 3 weeks) were administrated in 36 enrolled multiple primary lung cancer (MPLC) patients with persistent high-risk (Lung-RADS category 4 or had progressed within 6 months) GGOs...Collectively, PD-1 inhibitor showed certain activity on high-risk pulmonary GGO lesions without safety concerns. Such effects were associated with specific T-cell re-distribution, EGF/CTLA-4 cytokine compensation, and regulation of metabolism pathways.

P2, N=114, Recruiting, Sichuan University | Not yet recruiting --> Recruiting

P1, N=60, Recruiting, Shanghai Juncell Therapeutics | Trial primary completion date: Nov 2023 --> Nov 2024

P=N/A, N=70, Completed, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting --> Completed | Trial completion date: May 2025 --> Dec 2023 | Trial primary completion date: May 2025 --> Dec 2023

P2, N=40, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

P2, N=20, Recruiting, Sixth Affiliated Hospital, Sun Yat-sen University

P2, N=60, Not yet recruiting, Zhejiang Cancer Hospital

Sin+Chemo is a cost-effective first-line treatment option for advanced HER2-negative GC/GEJC in China. ORIENT-16, www.clinicaltrials.gov, identifier is NCT03745170.

P2, N=141, Recruiting, Shandong Cancer Hospital and Institute

P2, N=41, Active, not recruiting, West China Hospital | Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2024 --> Mar 2025

P=N/A, N=150, Recruiting, Zhejiang Cancer Hospital

P1, N=30, Recruiting, Wuhan Union Hospital, China

P2, N=20, Completed, The First Hospital of Jilin University | Unknown status --> Completed

P2, N=40, Recruiting, The First Affiliated Hospital with Nanjing Medical University

P2, N=57, Active, not recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

P1/2, N=381, Recruiting, Hutchmed | Trial completion date: Sep 2023 --> Dec 2025 | Trial primary completion date: Sep 2023 --> Dec 2025

P=N/A, N=300, Recruiting, Sun Yat-sen University

P2, N=43, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Trial primary completion date: Sep 2023 --> Sep 2024

P3, N=500, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting

P2, N=25, Not yet recruiting, Harbin Medical University

P=N/A, N=240, Recruiting, Sun Yat-sen University

P2, N=210, Recruiting, Fudan University

P2, N=49, Recruiting, Hubei Cancer Hospital | Not yet recruiting --> Recruiting | Initiation date: Sep 2023 --> Feb 2024

P2, N=140, Not yet recruiting, Sun Yat-sen University

P3, N=360, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Phase classification: P1b --> P3 | N=100 --> 360

P2, N=81, Not yet recruiting, Zhejiang Cancer Hospital

P2, N=20, Recruiting, The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Trial completion date: Sep 2023 --> Sep 2025

In conclusion, the chemo-free regimen pegaspargase plus sintilimab was effective and safe in newly diagnosed, advanced stage NKTCL. Dysregulated lipid profile and immunosuppressive signature contributed to treatment resistance, providing an alternative therapeutic approach dual targeting fatty acid metabolism and CTLA-4 in NKTCL.

P2, N=96, Not yet recruiting, Peking Union Medical College Hospital

P=N/A, N=30, Completed, Sun Yat-sen University | Recruiting --> Completed

P=N/A, N=600, Completed, Sun Yat-sen University | Trial completion date: Jul 2022 --> Jul 2023

In the randomized phase 2 CAPability-01 trial, we investigated the potential efficacy of combining the programmed cell death protein-1 (PD-1) monoclonal antibody sintilimab with the histone deacetylase inhibitor (HDACi) chidamide with or without the anti-vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab in patients with unresectable chemotherapy-refractory locally advanced or metastatic microsatellite stable/proficient mismatch repair (MSS/pMMR) colorectal cancer. Our study suggests that the combination of a PD-1 antibody, an HDACi, and a VEGF antibody could be a promising treatment regimen for patients with MSS/pMMR advanced colorectal cancer. ClinicalTrials.gov registration: NCT04724239 .

P2, N=114, Not yet recruiting, Sichuan University | Trial completion date: Nov 2026 --> Feb 2027 | Initiation date: Nov 2023 --> Feb 2024 | Trial primary completion date: Nov 2026 --> Feb 2027

P2, N=65, Recruiting, Fudan University

P3, N=327, Not yet recruiting, Avistone Biotechnology Co., Ltd.

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.

Biomarker analysis revealed that the breast cancer gene 2, BMP/Retinoic Acid Inducible Neural Specific 3, F-box/WD repeat-containing protein 7, tyrosine-protein kinase KIT and retinoblastoma 1 abnormalities led to shorter PFS, while ctDNA negative at baseline or clearance at 2 cycles of treatment was associated with longer PFS (18.1 vs. 4.3 months). Taken together, sintilimab in combination with 2 cycles of nab-paclitaxel/carboplatin treatment produced encouraging PFS and better tolerability as first-line treatment for advanced sq-NSCLC.

After the failure of comprehensive treatment containing sorafenib, camrelizumab and transhepatic arterial chemotherapy and embolization, 2 months after tumor relapse, the patient started to receive anlotinib and sintilimab. Anlotinib is a promising alternative for patients insensitive to the first-line targeted drugs. More clinical studies should be conducted to further broaden the clinical indications of anlotinib and immunotherapy in patients with HCC.

P=N/A, N=20, Recruiting, The First Hospital of Jilin University

The peripheral CD4+ T cell subpopulations demonstrated the high predictive value for therapeutic response and prolonged survival outcomes in advanced gastric cancer patients. CD4+ T cell subpopulations have the potential in predicting and screening benefit populations in advanced gastric cancer patients.

For the overall survival (OS) analysis, no statistically significant differences were observed between pembrolizumab [hazard ratios (HR) = 1.00, 95% CI: 0.94-1.07], sintilimab (HR = 0.99, 95% CI: 0.89-1.09), sugemalimab (HR = 0.98, 95% CI: 0.87-1.10), tislelizumab (HR = 0.97, 95% CI: 0.87-1.09), zolbetuximab (HR = 0.98, 95% CI: 0.91-1.07), and nivolumab (HR = 1.00). In addition, anti-claudin-18.2-targeted therapies presented similar OS (HR = 0.99, 95% CI: 0.95-1.04) and PFS (HR = 1.01, 95% CI: 0.91-1.12) compared to immunotherapy, although their toxicity profiles were distinct. Our network meta-analysis showed no significant difference in PFS, OS, or ORR between different checkpoint inhibitors or between immunotherapy and anti-claudin-18.2-targeted therapies in the first-line treatment of HER2-negative, unresectable, or metastatic gastric cancers.

P3, N=500, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd. | N=800 --> 500 | Trial completion date: Jun 2026 --> Oct 2028 | Trial primary completion date: Aug 2023 --> Sep 2026