Clinical trial NCT04188847: First-line Chemotherapy for Recurrent Cervical Cancer
Official title: Apatinib Combined With Cisplatin and Paclitaxel as First-line Chemotherapy for Recurrent or Persistent Advanced Cervical Cancer: A Single Arm, Single Center, Open, Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Cervical Carcinoma
Persistent Advanced Cervical Carcinoma
Chemotherapy
Vascular Endothelial Growth Factor 2 Inhibitor
Apatinib
Targeted Therapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A combination of cisplatin, paclitaxel and apatinib would be given for all patients
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate
timeFrame: One year
Secondary outcomes:
measure: Progression-free survival
timeFrame: One year
measure: Overall survival
timeFrame: One year
measure: Disease control rate
timeFrame: One year
measure: Adverse event rates
timeFrame: One years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: