A Phase 2 interventional study of Chemotherapy plus apatinib in Recurrent Cervical Carcinoma, Persistent Advanced Cervical Carcinoma and Chemotherapy, sponsored by Lei Li. Completed at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Lei Li · Phase 2, Interventional, and Treatment
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.
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's enrollment of 37 is below the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Lei Li is the lead sponsor of 62 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
The patients would accept the regimen of apatinib combined with cisplatin and paclitaxel
Drug: Chemotherapy plus apatinib
Drug page: Apatinib
A combination of cisplatin, paclitaxel and apatinib would be given for all patients: * Cisplatin: 50 mg/m2 body surface area, on the first day, every 3 weeks. If the creatinine clearance rate was less than 40 ml/min, the cisplatin would be replace by carboplatin (area under ther curve = 5) * Paclitaxel: 50 mg/m2 body surface area, on the first day, every 3 weeks * Apatinib: 250 mg every day The total courses of cisplatin and paclitaxel would be no more than 6.
Also known as: First line chemotherapy plus apatinib
Overall response rate
The rates of complete and partial remission
Time frame: One year
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
Time frame: One year
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.
Time frame: One year
Disease control rate
The rates of complete and partial remission, and stable disease
Time frame: One year
Adverse event rates
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
Time frame: One years
Plan to share: Yes — The individual participant data will be available by public reports.
Supporting information: Study protocol, Clinical study report
Time frame: Two year
Access criteria: Public reports
No publications or documents are linked to this record.
Ran from Dec 2019 to primary completion in Feb 2022, 26 months.
Of 132 non-industry phase 2 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 102. This study's 26 months is below that.
Counting every sponsor, half of 173 studies reached it within 42 months; a quarter within 29 and three quarters within 99.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Apatinib
Lei Li