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

Phase 2

• Conditions: Albumin-bound Paclitaxel; Immune Checkpoint Inhibitors; Recurrent Cervical Carcinoma; Persistent Advanced Cervical Carcinoma; Chemotherapy; Anti-PD-1 Antibody
• Interventions: Drug: Anti-PD-1 antibody camrelizumab; Drug: Albumin-bound paclitaxel

• Registration Number: NCT05290935
• Lead Sponsor: Lei Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-12
• Study First Submitted QC: 2022-03-12
• Last Update Submitted: 2022-03-12
• Study Start: 2022-03-13
• Study First Posted: 2022-03-22
• Last Update Posted: 2022-03-22
• Primary Completion: 2022-12-13
• Study Completion: 2024-03-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Anti-PD-1 antibody camrelizumab	The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel.
Study group	Albumin-bound paclitaxel	The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel.

Primary Outcome Measures

Name	Time	Method
Overall response rate	One year	The rates of complete and partial remission

Secondary Outcome Measures

Name	Time	Method
Overall survival	One year	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
Adverse event rates	One year	The rates of adverse events judged by Common Terminology Criteria for Adverse Events
Progression-free survival	One year	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
Disease control rate	One year	The rates of complete and partial remission, and stable disease

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China