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

NCT ID: NCT04680988

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-05
• Study Completion Date: 2025-07-07

Brief 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.

Detailed Description

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.The primary study hypotheses are that the combination of SHR-1210 plus SHR-1020 is superior to SHR-1210 or physician's choice chemotherapy with respect to: 1) Progression free survival(PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus SHR-1210；2) Overall survival(OS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus Physician's choice chemotherapy).

Conditions

Recurrent or Metastatic Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Doublet Arm

SHR-1210+SHR-1020

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

SHR-1210 intravenously every 3 weeks

SHR-1020

Intervention Type: DRUG

SHR-1020 Orally once daily

Single Arm

SHR-1210

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

SHR-1210 intravenously every 3 weeks

Physician's choice chemotherapy

Albumin-bound paclitaxel injection or Pemetrexed disodium for injection or Gemcitabine for injection

Group Type: ACTIVE_COMPARATOR

Physician's choice chemotherapy

Intervention Type: DRUG

Investigators will declare one of the following regimens:Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection

Interventions

SHR-1210

SHR-1210 intravenously every 3 weeks

Intervention Type: DRUG

SHR-1020

SHR-1020 Orally once daily

Intervention Type: DRUG

Physician's choice chemotherapy

Investigators will declare one of the following regimens:Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection

Intervention Type: DRUG

Other Intervention Names

Camrelizumab; Famitinib; Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40561369 (View on PubMed)

Other Identifiers

SHR-1210-II-217

Identifier Type: -

Identifier Source: org_study_id