Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy

Study Overview
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Brief Summary
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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 34 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for first 9 patients. If at least total 2 patients achieved complete or partial remission, or at least total 6 patients achieved complete or partial remission or stable disease, the same regimen would be given for rest 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, Single Center, Open, Phase II Trial

Conditions
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Recurrent Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Chemotherapy, Anti-PD-1 Antibody, Immunotherapy

Intervention / Treatment
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* Drug: A combination of anti-PD-1 antibody camrelizumab and 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: A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel<br>* A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients: 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 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 | 
| Remission duration | The duration of complete and partial remission | One years | 
| Adverse event rates | The rates of adverse events judged by Common Terminology Criteria for Adverse Events | One year |