Tyvyt (sintilimab)

P=N/A, N=80, Recruiting, Hunan Cancer Hospital

P2, N=90, Recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting --> Recruiting

Considering the interplay between cancer, inflammation, and immunosuppression, we hypothesized that circulating and imaging inflammatory markers could serve as indicators of anti-tumor immune responses, and thus conducting an exploratory study to reveal the predictive value of combining longitudinal systemic inflammatory markers in stratifying pathologic response to neoadjuvant sintilimab...The combination of pre-treatment SLR and ΔNLR% demonstrates predictive value in stratifying pathologic response to neoadjuvant immunotherapy in resectable NSCLC. The high inflammatory burden group had the lowest pathologic regression and the pre-treatment immunosuppressive microenvironment with macrophage enrichment.

To the best of our knowledge, this is the first clinical case report in the literature describing the benefit of anlotinib and sintilimab treatment for non-small cell lung cancer with RET fusion and high PD-L1 expression. This study explores the biomarker selection for targeted therapy and combined immunotherapy in NSCLC patients.

P2, N=110, Not yet recruiting, Qilu Hospital of Shandong University

Unfortunately, the patient progressed rapidly during maintenance therapy when cadonilimab was replaced by sintilimab, the monoclonal antibody against PD-1, indicating the more powerful anti-tumor activity of dual blockade immunotherapy. To conclude, cadonilimab offers a promising and effective therapeutic approach for R/M CC. Notably, HER-2 is also expected to be a new reference target for cadonilimab therapy.

P2, N=68, Recruiting, Fudan University

Given the high expression of programmed cell death-ligand 1, the patient was treated with sintilimab immunotherapy...Notably, both the primary lung tumor and cardiac metastases were markedly reduced in size, indicating a positive therapeutic response. The present case underscores the potential efficacy of immunotherapy in the management of cardiac metastases originating from lung cancer.

P2, N=40, Completed, Wuhan University | Recruiting --> Completed | Trial completion date: Dec 2023 --> Nov 2024 | Trial primary completion date: Aug 2023 --> Nov 2024

He was given sintilimab and anlotinib as first line treatment...Subsequently, the second line regimen was modified to etoposide and cisplatin (EP) combined with anlotinib and penpulimab...Notably, the patient's progress-free survival (PFS) exceeds 7 months and the overall survival up to 12 months. Our case implies that a combination of chemotherapy, anlotinib, and penpulimab might offer a promising therapeutic approach for PD-L1-negative thoracic SMARCA4-UT.

Finding suggests that immune checkpoint inhibitors combined with chemotherapy could enrich patients with benefits regardless of CPS grades, though subtle efficacy in low CPS subgroups. This study compared the efficacy of different immunotherapies combined with chemotherapy in patients with gastric cancer, but we acknowledge some differences between reconstructed and original data. Hopefully there will be more research investigating comparisons between current therapies rather than with chemotherapy only in the future.

P2, N=112, Recruiting, The First Affiliated Hospital of Zhengzhou University

P2, N=29, Completed, Zhejiang Cancer Hospital | Recruiting --> Completed | Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Dec 2021 --> Sep 2024

P2, N=86, Recruiting, Anhui Provincial Cancer Hospital

P=N/A, N=50, Recruiting, The First Hospital of Jilin University

P3, N=430, Recruiting, Chipscreen Biosciences, Ltd. | Not yet recruiting --> Recruiting

P1/2, N=36, Active, not recruiting, Sun Yat-sen University | Trial completion date: Oct 2024 --> Oct 2025

P2, N=40, Active, not recruiting, Sun Yat-sen University | Trial completion date: Dec 2024 --> Dec 2025

P2, N=52, Recruiting, Shanghai Chest Hospital

P1/2, N=33, Not yet recruiting, Shanghai Gynecologic Oncology Group | Initiation date: Oct 2024 --> Jan 2025

Compared with chemotherapy alone, Sintilimab or camrelizumab plus chemotherapy seemed to achieve the best progression-free survival (hazard ratio = 0.56, 95% CI 0.46-0.68)...Nivolumab plus ipilimumab resulted in a relatively lower incidence of adverse events of grade ≥3 than other regimens. The combination of immune checkpoint inhibitors (ICIs) with chemotherapy provided a high probability of more effective treatment in comparison with chemotherapy alone for patients with advanced ESCC. Toripalimab and sintilimab plus chemotherapy were ranked as providing the highest OS and PFS benefit in the first-line setting, respectively.

P=N/A, N=50, Not yet recruiting, Guiping People's Hospital

P2, N=98, Not yet recruiting, Shanghai Juncell Therapeutics

P=N/A, N=1500, Recruiting, Tianjin Medical University Cancer Institute and Hospital

This study provides a unique single-cell resource with clonal and longitudinal resolution during ICI therapy and reveals IFN signaling as a biomarker of immunotherapy response in HCC, suggesting a beneficial effect by combining IFN inducers with ICIs for patients with HCC.

The combination of sintilimab and decitabine shows promise efficacy for higher-risk MDS, with a favorable safety profile. The potential predictive value of T cell exhaustion biomarkers might help screen the possible benefiting population.

In intermediate-to-advanced HCC, the BeSiIT and LeSiIT groups exhibited acceptable toxicities and comparable PFS, OS, and ORR.

ICIs in combination with bevacizumab can not only improve the patient's prognosis but also yield safe and controllable adverse drug reactions in patients suffering from MSS/pMMR advanced CRC after failure to a 1st-line therapy.

Tail effect is a golden tail of immunotherapy. This case illustrates that the tail effect of immunotherapy can offer substantial survival benefits for patients with unresectable advanced lung cancer who have failed chemotherapy.

P2, N=96, Not yet recruiting, Yugui Lian

P2, N=27, Not yet recruiting, Ruijin Hospital

We showed that a pathological complete response (pCR) can be obtained even with unresectable advanced GC through treatment with sintilimab combined with neoadjuvant chemotherapy and trastuzumab.

P=N/A, N=20, Recruiting, Ruijin Hospital | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025

P1, N=6, Recruiting, Second Xiangya Hospital of Central South University | Not yet recruiting --> Recruiting

P2, N=4, Terminated, Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting --> Terminated; After careful consideration, our company has decided to revise the overall development strategy for IBI310 and discontinue further registration research for this project. Consequently, the ongoing screening process will be terminated, and this decisi

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

P2, N=200, Not yet recruiting, Peking University Shenzhen Hospital

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