First-line Chemotherapy for Recurrent Cervical Cancer

Lei Li

Status and phase

Completed

Phase 2

Conditions

Targeted Therapy

Chemotherapy

Vascular Endothelial Growth Factor 2 Inhibitor

Persistent Advanced Cervical Carcinoma

Recurrent Cervical Carcinoma

Apatinib

Treatments

Drug: Chemotherapy plus apatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT04188847

REPACC-1

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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