Camrelizumab Combined With Famitinib Malate and Chemotherapy for Treatment of Recurrent/ Metastatic Cervical Cancer

NCT07627620 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-CervC-II-011
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is an open-label, multi-center Phase II clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate and platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer.

Conditions

Cervical Cancer

Keywords

Cervical Cancer; Chemotherapy; Camrelizumab; Famitinib malate

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Objective Response Rate defined as the percentage of participants who have a complete response or a partial response (PR) per RECIST 1.1.

  up to 2 years

Secondary Outcomes (6)

• Disease control rate (DCR)

  up to 2 years

• Duration of response (DOR)

  Up to 2 years

• Time to response (TTR)

  up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

Study Arms (1)

Camrelizumab combined with famitinib malate and chemotherapy

EXPERIMENTAL

Drug: Camrelizumab; Drug: Famitinib Malate; Drug: Chemotherapy

Interventions

Camrelizumab DRUG

Intravenous (IV) on Day 1 of each cycle

Camrelizumab combined with famitinib malate and chemotherapy

Famitinib Malate DRUG

Famitinib po qd

Camrelizumab combined with famitinib malate and chemotherapy

Chemotherapy DRUG

Paclitaxel + cisplatin or carboplatin

Camrelizumab combined with famitinib malate and chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged 18-75 years.
• Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy.
• No prior systemic anti-cancer therapy for recurrent/metastatic disease.
• According to RECIST v1.1 criteria, the patient must have at least one measurable lesion.
• Able to normally swallow drug tablets
• Has adequate organ function.
• Willing to participate and able to comply with research programme requirements.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Estimated life expectancy of more than 3 months.

You may not qualify if:

• Has any malignancy \<5 years prior to study entry.
• Known to have brain or meningeal metastasis.
• Known to have autoimmune disease.
• Received live vaccinations 4 weeks before randomization or during the study period.
• Known allergies and contraindications to the investigational drug or any of its components.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

camrelizumab; Drug Therapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jie Tang

CONTACT

0731-89762071; tangjie@hnca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 30, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share