drugset / Trial / NCT04188847

First-line Chemotherapy for Recurrent Cervical Cancer

NCT04188847 ↗

Phase 2 Completed 37 enrolled Lei Li
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2019-12-06
Primary completion
2022-02-06
Completion
2022-03-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — —
Subject Cisplatin Other / unclassified 50 mg/m2 —
Subject Paclitaxel Small molecule 50 mg/m2 —
Subject Rivoceranib Small molecule 250 mg —

Indications