Clinical trial · Interventional
First-line Chemotherapy for Recurrent Cervical Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Apatinib | — | UNRESOLVED | — |
| Chemotherapy | — | UNRESOLVED | — |
| Persistent Advanced Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
| Targeted Therapy | — | UNRESOLVED | — |
| Vascular Endothelial Growth Factor 2 Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy plus apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group
- description
- The patients would accept the regimen of apatinib combined with cisplatin and paclitaxel
- interventionNames
- Drug: Chemotherapy plus apatinib
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- One year
- description
- The rates of complete and partial remission
Secondary outcomes (4)
- measure
- Progression-free survival
- timeFrame
- One year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available