Tyvyt (sintilimab)

P2, N=36, Recruiting, Sun Yat-sen University | Trial completion date: Nov 2025 --> Dec 2027 | Trial primary completion date: Nov 2024 --> Dec 2027

Further validation in larger, histology-specific patients is needed to confirm clinical benefit. https://www.chictr.org.cn/; ID: ChiCTR1900024488.

Sintilimab plus lenvatinib showed heterogeneous efficacy in HCC. High LINC01554 expression, elevated CD4+ Tcm cells, and solitary tumors may serve as predictive biomarkers for prolonged disease control.

Sintilimab failed to improve PFS-6 in both grade 1 and grade 2/3 recurrent/progressive meningiomas in this single-arm, single-center, and small-sample trial. When evaluating PD-1 inhibitor treatment for recurrent/progressive meningioma patients, who generally have a longer expected survival and high TMB, the use of the Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria may be more appropriate to avoid overlooking potential clinical benefits.

The treatment journey involved surgical resection, followed by chemotherapy with albumin-bound paclitaxel and carboplatin, and finally immunotherapy with sintilimab. Significantly, this is the first-ever report of the efficacy of sintilimab in PD-L1-high PEH, filling a critical gap in the existing literature. This case not only underscores the potential of sintilimab in PD-L1-high PEH but also sets a precedent for further exploration of immune checkpoint inhibitors in this rare disease.

P2, N=460, Recruiting, The First Affiliated Hospital with Nanjing Medical University

P1, N=43, Completed, Shanghai Juncell Therapeutics | Recruiting --> Completed | Trial completion date: Apr 2026 --> Oct 2025 | Trial primary completion date: Nov 2025 --> Apr 2025

Our findings directly inform clinical guidelines, address gaps in current therapeutic decision-making. Durvalumab or pembrolizumab combined with GC are optimal first-line regimens for advanced BTC, balancing survival benefits and safety. Sintilimab plus anlotinib combined with GC demonstrates superior PFS but requires further validation. While EGFR inhibitors plus chemotherapy demonstrate potential in KRAS wild-type patients, confirmation in large-scale RCTs is required. PD-L1 expression may represent a promising predictive biomarker for response to PD-1 inhibitor therapy.

Given the patient's advanced age, poor physical condition, and refusal of surgery, a palliative treatment plan of "Raltitrexed + Sintilimab" was finally decided upon after a multidisciplinary consultation. This case highlights the importance of adequate sampling in the diagnosis of gastric squamous cell carcinoma to avoid misdiagnosis due to limited specimens. It also provides a potential treatment option of immune therapy combined with low-dose chemotherapy for elderly patients with gastric squamous cell carcinoma who are not suitable for surgery.

P2, N=70, Recruiting, Zhejiang University

P2, N=30, Recruiting, Peking University Cancer Hospital & Institute | Not yet recruiting --> Recruiting

P1/2, N=88, Recruiting, West China Hospital | Not yet recruiting --> Recruiting