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

NCT ID: NCT05290935

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-13
• Study Completion Date: 2024-03-13

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel.

Group Type: EXPERIMENTAL

Anti-PD-1 antibody camrelizumab

Intervention Type: DRUG

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

Intervention Type: DRUG

Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses

Interventions

Anti-PD-1 antibody camrelizumab

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

Intervention Type: DRUG

Albumin-bound paclitaxel

Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lei Li

OTHER

Sponsor Role: lead

Responsible Party

Lei Li

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Lei Li

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Li, M.D.

Role: CONTACT

lileigh@163.com

10-139-1198-8831

Facility Contacts

Lei Li, MD

Role: primary

lileigh@163.com

008613911988831

Other Identifiers

REPACC-3

Identifier Type: -

Identifier Source: org_study_id