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NCT04188847

First-line Chemotherapy for Recurrent Cervical Cancer

Completed Phase 2 Last updated 15 March 2022
What this trial tests

Phase 2 trial testing Chemotherapy plus apatinib in Recurrent Cervical Carcinoma in 37 participants. Completed in 13 March 2022.

Timeline
6 December 2019
Primary endpoint
6 February 2022
13 March 2022

Quick facts

Lead sponsorLei Li
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment37
Start date6 December 2019
Primary completion6 February 2022
Estimated completion13 March 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Lei Li — full company profile →

Who can join

Adults 18 to 75, female only, with Recurrent Cervical Carcinoma or Persistent Advanced Cervical Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Combat Against Gynecological Cancers with Blood Vessels as Entry Point: Anti-Angiogenic Drugs, Clinical Trials and Pre-Clinical Nano-Delivery Platforms.
    Yang S, Fei W, Zhao Y, Wang F, et al · · 2023 · cited 11× · PMID 37312935 · DOI 10.2147/ijn.s411761

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Other recruiting trials for Recurrent Cervical Carcinoma

Currently open trials in the same condition.

Other Lei Li trials

Trials by the same sponsor.

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