- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04188847
First-line Chemotherapy for Recurrent Cervical Cancer
March 12, 2022 updated by: Lei Li
Apatinib Combined With Cisplatin and Paclitaxel as First-line Chemotherapy for Recurrent or Persistent Advanced Cervical Cancer: A Single Arm, Single Center, Open, Phase II Trial
The response rate of traditional first-line chemotherapy for recurrent or persistent advanced cervical cancer was low.
This single arm, open, phase II trial would recruit 37 eligible patients.
A combination of cisplatin, paclitaxel and apatinib would be given for first 23 patients.
If at least 13 patients achieved complete or partial remission, the same regimen would be given for rest 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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
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 Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- 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
- An interval of 3 months or more since the fulfilling of last treatment
- 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 a history of exposure to other antiangiogenic agents
- With other malignancies within past 3 years
- With vital complications
- With uncontrolled hypertension despite of medical treatment
- With severe cardiac disease, coagulation disorders, bleeding disorders, vascular diseases, deep venous thrombosis
- With brain metastasis
- With addiction to psychiatric medications or with mental disorders
- With severe open trauma, fracture or major surgery with past 4 weeks
- With disorders which would hamper the absorption of oral drugs, or with intestinal perforation or ileus with past 6 months
- Urine protein ≥++, or 24 hr urine protein ≥1.0 g
- 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 would accept the regimen of apatinib combined with cisplatin and paclitaxel
|
A combination of cisplatin, paclitaxel and apatinib would be given for all patients:
Other Names:
|
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
|
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
|
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 years
|
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
|
One years
|
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)
December 6, 2019
Primary Completion (Actual)
February 6, 2022
Study Completion (Actual)
March 13, 2022
Study Registration Dates
First Submitted
December 4, 2019
First Submitted That Met QC Criteria
December 4, 2019
First Posted (Actual)
December 6, 2019
Study Record Updates
Last Update Posted (Actual)
March 15, 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
Other Study ID Numbers
- REPACC-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The individual participant data will be available by public reports.
IPD Sharing Time Frame
Two year
IPD Sharing Access Criteria
Public reports
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
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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