Camrelizumab Combined With Famitinib Malate and Chemotherapy for Treatment of Recurrent/ Metastatic Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Camrelizumab, Famitinib Malate, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Camrelizumab
Intravenous (IV) on Day 1 of each cycle - Drug Famitinib Malate
Famitinib po qd - Drug Chemotherapy
Paclitaxel + cisplatin or carboplatin
Primary outcome measures
- Objective response rate (ORR) [Time frame: up to 2 years]
Secondary outcome measures (6)
- Disease control rate (DCR) [Time frame: up to 2 years]
- Duration of response (DOR) [Time frame: Up to 2 years]
- Time to response (TTR) [Time frame: up to 2 years]
- Progression-free survival (PFS) [Time frame: Up to 2 years]
- Overall Survival (OS) [Time frame: Up to 2 years]
- Safety [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07627620 · MA-CervC-II-011