First-line Chemotherapy for Recurrent Cervical Cancer

Sponsor
Lei Li
Study ID
NCT04188847
Phase
PHASE2
Status
Completed

Conditions

  • Apatinib
  • Chemotherapy
  • Persistent Advanced Cervical Carcinoma
  • Recurrent Cervical Carcinoma
  • Targeted Therapy
  • Vascular Endothelial Growth Factor 2 Inhibitor

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy plus apatinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 6, 2019
Status verified
Mar 2022
Primary completion
Feb 6, 2022
Completion
Mar 13, 2022

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study group
    The patients would accept the regimen of apatinib combined with cisplatin and paclitaxel

Primary Outcome Measure

Overall response rate [ Time Frame: One year ]

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