Tyvyt (sintilimab)

Our findings provide a new molecular portrait of cell compositions associated with ICB resistance in patients with GCPM and aid in the prioritisation of therapeutic candidates to potentiate immunotherapy.

This study will provide evidence for the efficacy and safety of the combination of immunochemotherapy and cryoablation as a first-line treatment for advanced NSCLC. Although it has a limited sample size, the findings of this study will be used in the future to inform the design of a fully powered, 2-arm, larger-scale study.

P2, N=30, Not yet recruiting, Shanghai Chest Hospital

P3, N=560, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting

P2, N=51, Recruiting, Fudan University | Trial completion date: Sep 2025 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026

P=N/A, N=40, Not yet recruiting, The First Affiliated Hospital Of Zhengzhou University; The First Affiliated Hospital Of Zhengzhou University

P4, N=100, Not yet recruiting, Anhui Chest Hospital; Anhui Chest Hospital

P2, N=400, Recruiting, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

P2/3, N=52, Not yet recruiting, Nanjing Drum Tower Hospital; Nanjing Drum Tower Hospital

P2, N=50, Not yet recruiting, The First Affiliated Hospital of Guangxi Medical University; The First Affiliated Hospital of Guangxi Medical University

P2, N=38, Not yet recruiting, Shanghai Eastern Hepatobiliary Surgery Hospital; Shanghai Eastern Hepatobiliary Surgery Hospital

P1/2, N=62, Recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

P1, N=20, Not yet recruiting, Zhongshan Hospital; Zhongshan Hospital

P2, N=150, Not yet recruiting, First Affiliated Hospital of Guangxi Medical University

The combination regimen demonstrated promising efficacy in treating unresectable HCC, accompanied by manageable safety profiles. Furthermore, the results of this investigation suggest that AFP holds promise as predictive biomarkers for this treatment strategy.

P2, N=82, Not yet recruiting, Shanghai Zhongshan Hospital | Trial completion date: Jul 2028 --> Dec 2028 | Initiation date: Jul 2024 --> Nov 2024 | Trial primary completion date: Jul 2027 --> Dec 2027

P2, N=58, Active, not recruiting, West China Hospital

P2, N=29, Completed, Fudan University | Recruiting --> Completed

P2, N=110, Not yet recruiting, Fudan University

P2, N=33, Recruiting, West China Hospital

In our study, preliminary evidence provided the anticancer activity and acceptable adverse effects of sintilimab administered every 3 weeks to pretreated patients with mTNBC. Sintilimab showed its efficacy and safety of immunotherapy for patients with advanced TNBC.

Significant tumor microenvironment changes were observed in pCR patients, including reduced VEGF+ cells and CD4+Foxp3+ Treg cells, and increased perivascular CD4+ T cells, CD39+CD8+ T cells, and M1 macrophages. In conclusion, perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy achieved pCR in a notable proportion of patients with resectable NSCLC and were associated with profound changes in the tumour microenvironment (ClinicalTrials.gov NCT05400070).

P2, N=124, Not yet recruiting, Fudan University

This study supports the cost-effectiveness of using sintilimab in combination with chemotherapy. Nevertheless, the cost-effectiveness of combining sintilimab with IBI305 and chemotherapy in this particular patient group may be lacking.

P1, N=12, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Recruiting --> Completed | Phase classification: P1a/1b --> P1 | N=48 --> 12

P=N/A, N=15, Not yet recruiting, Fujian Provincial Hospital

12 patients received Nivolumab plus Ipilimumab regimen and 8 patients received PD-1 blockades (2 patients were Pembrolizumab, 2 patients were Sintilimab, 4 patients were Tislelizumab) monotherapy. Furthermore, the study suggested that dual immunotherapy could potentially increase the immunotherapy cycle and contribute to a superior pCR rate. However, the conclusion emphasized the need for further prospective clinical trials to validate these results.

Combination kinase inhibitors with immunotherapy as first-line therapy are safe and effective for the treatment of unresectable ATC, especially with BRAF V600E mutation.

P2, N=200, Not yet recruiting, Xijing Hospital | Initiation date: Jul 2024 --> Dec 2024

P=N/A, N=84, Recruiting, First Hospital of China Medical University

P=N/A, N=97, Active, not recruiting, First Hospital of China Medical University

P=N/A, N=228, Recruiting, First Hospital of China Medical University

P3, N=219, Recruiting, Henan Cancer Hospital | Active, not recruiting --> Recruiting

P3, N=560, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.

P=N/A, N=42, Recruiting, Sun Yat-sen University

P2, N=296, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China

P2, N=43, Not yet recruiting, Sun Yat-sen University

Sintilimab plus GemOx showed encouraging activity and manageable toxicity for patients with r/r PTCL.

Moreover, in scenario analysis, the results remained consistent despite variations in the model's time frame. In China, SINT + Chemo is a more cost-effective option (vs. chemotherapy) as a first-line therapy for unresectable advanced or metastatic GC/GEJC, irrespective of PD-L1 expression levels.

P2, N=20, Recruiting, Shanghai 6th People's Hospital

P2, N=29, Active, not recruiting, Wuhan Union Hospital, China | Not yet recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Dec 2024

P2, N=51, Active, not recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting --> Active, not recruiting | Trial completion date: May 2026 --> Jan 2027