Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial

Study Overview
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Brief Summary
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This is a updated trial of NCT04188860 as a multi-center study. For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. The marketing of anti-PD-1 antibody has provided an opportunity of curative management. This single arm, open, phase II trial would recruit 122 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.

Official Title
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Anti-PD-1 Antibody Camrelizumab Combined With Albumin-bound Paclitaxel for Recurrent and Persistent Advanced Cervical Cancer Refractory to Platinum-based Chemotherapy: A Single Arm, Multi-Center, Open, Phase II Trial

Conditions
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Recurrent Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Chemotherapy, Immune Checkpoint Inhibitors, Anti-PD-1 Antibody, Albumin-bound Paclitaxel

Intervention / Treatment
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* Drug: Anti-PD-1 antibody camrelizumab
* Drug: Albumin-bound paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female of 18-75 years old Eastern Cooperative Oncology Group score 0-1 Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure Having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1 Anticipative survival period of 3 months or more Lab testing within reference ranges With appropriate contraception Provided consents of participating the trial Exclusion Criteria: With brain metastasis With addiction to psychiatric medications or with mental disorders With following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of > 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment With infective disease which need systematic treatment within 14 days With severe open trauma, fracture or major surgery with past 4 weeks With potential allergy or intolerance to study regimens Not eligible for the study judged by researchers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel. | Drug: Anti-PD-1 antibody camrelizumab<br>* Camrelizumab: 200 mg every time, every 3 weeks, which would be sustained until the appearance of disease progression on intolerable adverse events, and no more than 24 months<br>Drug: Albumin-bound paclitaxel<br>* Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | The rates of complete and partial remission | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | The length of time during and after the treatment of the cancer, that a patient lives with the disease but it does not get worse | One year | 
| Overall survival | The length of time from either the date of diagnosis or the start of treatment for the cancer, that patients diagnosed with the disease are still alive | One year | 
| Disease control rate | The rates of complete and partial remission, and stable disease | One year | 
| Adverse event rates | The rates of adverse events judged by Common Terminology Criteria for Adverse Events | One year |