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

A Multi-Center Phase II Clinical Study of Camrelizumab Combined With Famitinib Malate and Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: Camrelizumab; Drug: Famitinib Malate; Drug: Chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jie Tang; Phone Number: 0731-89762071; Email: tangjie@hnca.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab combined with famitinib malate and chemotherapy	Drug: Camrelizumab; Intravenous (IV) on Day 1 of each cycle; Drug: Famitinib Malate; Famitinib po qd; Drug: Chemotherapy; Paclitaxel + cisplatin or carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate (DCR)	DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.	up to 2 years
Duration of response (DOR)	Duration of Response per RECIST 1.1.	Up to 2 years
Time to response (TTR)	TTR is defined as the time from the date of first dose until the date of first documented response per RECIST 1.1.	up to 2 years
Progression-free survival (PFS)	PFS is defied as time from the date of first dose to first documented of disease progression (RECIST1.1) or date of death.	Up to 2 years
Overall Survival (OS)	OS was defined as the time from the date of first dose until death due to any cause.	Up to 2 years
Safety	Incidence, type and severity of adverse events	Up to 2 years

Collaborators and Investigators

• Sponsor: Hunan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: May 31, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cervical Cancer; Chemotherapy; Camrelizumab; Famitinib malate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Therapeutics; Drug Therapy; camrelizumab
• Other Study ID Numbers: MA-CervC-II-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No