Clinical trial · Interventional
A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer
A Randomized,Open-label, Multi-Center, Phase II Clinical Trial to Assess the Efficacy and Safety of SHR-1210± SHR-1020 Versus Physician's Choice Chemotherapy in the Treatment of Recurrent or Metastatic Cervical Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Metastatic Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physician's choice chemotherapy | Drug | — | UNRESOLVED |
| SHR-1020 | Drug | — | UNRESOLVED |
| SHR-1210 | Drug | Camrelizumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Doublet Arm
- description
- SHR-1210+SHR-1020
- interventionNames
- Drug: SHR-1210
- Drug: SHR-1020
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- SHR-1210
- interventionNames
- Drug: SHR-1210
- type
- ACTIVE_COMPARATOR
- label
- Physician's choice chemotherapy
- description
- Albumin-bound paclitaxel injection or Pemetrexed disodium for injection or Gemcitabine for injection
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntarily agree to participate by giving written informed consent. 2. Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix. 3. The patients relapsed after a platinum-based treatment regimen for recurrent or metastatic disease. 4. Patients must provide a fresh biopsy. If not, sufficient and adequate tumor tissue sample from the most recent biopsy of a tumor lesion will be required for PD-L1 expression. 5. Has measurable lesion on imaging based on RECIST version 1.1. 6. Have a life expectancy of at least 3 months. 7. ECOG performance status 0-1. 8. If childbearing potential, female patients must be willing to use at least 1 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study treatment. Exclusion Criteria: 1. Has any malignancy \<5 years prior to study entry. Except for curative skin basal cell carcinoma, carcinoma in situ or breast cancer \>3 years. 2. Has received prior therapy with: anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies; Famitinib; patient is allergic to monoclonal antibody. 3. Known to have autoimmune disease. 4. Recived other anticancer therapy 4 weeks before randomization. 5. Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus. 6. Untreated and/or uncontrolled brain metastases. 7. With high risk of vaginal bleeding or gastrointestinal perforation.
References
Publications (1)
- DERIVEDXia 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. PMID 40561369