Overview

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

Status:
Recruiting
Trial end date:
2024-03-13
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lei Li
Treatments:
Albumin-Bound Paclitaxel
Antibodies
Paclitaxel
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