- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05290935
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial
March 12, 2022 updated by: Lei Li
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
122
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lei Li, M.D.
- Phone Number: 10-139-1198-8831
- Email: lileigh@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Lei Li
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: One year
|
The rates of complete and partial remission
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 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
|
One year
|
Disease control rate
Time Frame: One year
|
The rates of complete and partial remission, and stable disease
|
One year
|
Adverse event rates
Time Frame: One year
|
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
|
One year
|
Overall survival
Time Frame: 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
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2022
Primary Completion (Anticipated)
December 13, 2022
Study Completion (Anticipated)
March 13, 2024
Study Registration Dates
First Submitted
March 12, 2022
First Submitted That Met QC Criteria
March 12, 2022
First Posted (Actual)
March 22, 2022
Study Record Updates
Last Update Posted (Actual)
March 22, 2022
Last Update Submitted That Met QC Criteria
March 12, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Carcinoma
- Recurrence
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Antibodies
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- REPACC-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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