A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer

Summary

This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.

Timeline

Start

2021-04-05

Primary completion

2025-07-07

Completion

2025-07-07

Outcome

Met primary endpoint

paper ORR per BICR was significantly improved with camrelizumab-famitinib compared with camrelizumab PMID 40561369 ↗

paper difference, 16.9% [95% CI, 2.1 to 31.7]; one-sided P = .0181 PMID 40561369 ↗

Publications

• Xia L, Zhang K, Tang Y, Zhang G, Wang D, Lou H, Liu N, Zhang H, Chen H, Wang K, Wei S, Wang L, Gao K, Li G, Zhang H, Hu Y, Zhao W, Zhang Y, Zhu H, Lin A, Miao J, Yu G, Hua K, Tang L, Liu Z, Zhang B, Li H, Zheng M, Wang X, Li F, Yang X, Zhou H, Xia B, Zhou X, Wang Y, Wang Q, Wu X. Camrelizumab Plus Famitinib versus Camrelizumab Alone and Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer: A Randomized, Phase II Study. J Clin Oncol. 2025 Aug 20;43(24):2720-2733. doi: 10.1200/JCO-24-02495. Epub 2025 Jun 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Camrelizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Famitinib	Small molecule	20 mg	Oral
Comparator	Gemcitabine	Small molecule	—	—
Comparator	Paclitaxel	Small molecule	—	—
Comparator	Pemetrexed	Small molecule	—	—

Indications

No indication recorded.