Back to resultsImmunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial
Primary Purpose
Recurrent Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Chemotherapy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anti-PD-1 antibody camrelizumab
Albumin-bound paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Cervical Carcinoma
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
Sites / Locations
- Lei LiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel.
Outcomes
Primary Outcome Measures
Overall response rate
The rates of complete and partial remission
Secondary Outcome Measures
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
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
Disease control rate
The rates of complete and partial remission, and stable disease
Adverse event rates
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05290935
Brief Title
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2022 (Actual)
Primary Completion Date
December 13, 2022 (Anticipated)
Study Completion Date
March 13, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Chemotherapy, Immune Checkpoint Inhibitors, Anti-PD-1 Antibody, Albumin-bound Paclitaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel.
Intervention Type
Drug
Intervention Name(s)
Anti-PD-1 antibody camrelizumab
Intervention Description
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
Intervention Name(s)
Albumin-bound paclitaxel
Intervention Description
Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses
Primary Outcome Measure Information:
Title
Overall response rate
Description
The rates of complete and partial remission
Time Frame
One year
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
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
Time Frame
One year
Title
Overall survival
Description
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
Time Frame
One year
Title
Disease control rate
Description
The rates of complete and partial remission, and stable disease
Time Frame
One year
Title
Adverse event rates
Description
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Li, M.D.
Phone
10-139-1198-8831
Email
lileigh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Li, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Li, MD
Phone
008613911988831
Email
lileigh@163.com
12. IPD Sharing Statement
Learn more about this trial
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial
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