First-line Chemotherapy for Recurrent Cervical Cancer

Phase 2

Completed

• Conditions: Recurrent Cervical Carcinoma; Persistent Advanced Cervical Carcinoma; Chemotherapy; Vascular Endothelial Growth Factor 2 Inhibitor; Apatinib; Targeted Therapy
• Interventions: Drug: Chemotherapy plus apatinib

• Registration Number: NCT04188847
• Lead Sponsor: Lei Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-04
• Study Start: 2019-12-06
• Study First Posted: 2019-12-06
• Primary Completion: 2022-02-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-12
• Study Completion: 2022-03-13
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Chemotherapy plus apatinib	The patients would accept the regimen of apatinib combined with cisplatin and paclitaxel

Primary Outcome Measures

Name	Time	Method
Overall response rate	One year	The rates of complete and partial remission

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	One year	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
Overall survival	One year	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.
Disease control rate	One year	The rates of complete and partial remission, and stable disease
Adverse event rates	One years	The rates of adverse events judged by Common Terminology Criteria for Adverse Events

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China