Cervical Cancer
Conditions
Keywords
Cervical Cancer, Chemotherapy, Camrelizumab, Famitinib malate
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.
Interventions
DRUGCamrelizumab
Intravenous (IV) on Day 1 of each cycle
DRUGFamitinib Malate
Famitinib po qd
DRUGChemotherapy
Paclitaxel + cisplatin or carboplatin
Sponsors
Hunan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | up to 2 years | Objective Response Rate defined as the percentage of participants who have a complete response or a partial response (PR) per RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | up to 2 years | DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1. |
| Duration of response (DOR) | Up to 2 years | Duration of Response per RECIST 1.1. |
| Time to response (TTR) | up to 2 years | TTR is defined as the time from the date of first dose until the date of first documented response per RECIST 1.1. |
| Progression-free survival (PFS) | Up to 2 years | PFS is defied as time from the date of first dose to first documented of disease progression (RECIST1.1) or date of death. |
| Overall Survival (OS) | Up to 2 years | OS was defined as the time from the date of first dose until death due to any cause. |
| Safety | Up to 2 years | Incidence, type and severity of adverse events |
Contacts
CONTACTJie Tang
Outcome results
None listed