Clinical trial · Interventional
Postoperative Concurrent Chemoradiotherapy Combined With Endostar for High-risk Early Stage Cervical Cancer
Postoperative Concurrent Chemoradiotherapy Combined With Recombinant Human Endostatin for High-risk Early Stage Cervical Cancer: A Phase II Pilot Study (ChESS).
NCT03622827CI-TRIAL-00034349ChESSunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To assess the efficacy and safety of postoperative concurrent chemoradiotherapy combined with recombinant human endostatin (Endostar) in patients with high-risk early stage cervical cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiotherapy+ Endostar | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemoradiotherapy + Endostar
- description
- Chemoradiotherapy with Endostar: * Chemoradiotherapy: pelvic radiotherapy with concurrent chemotherapy that consisted of cisplatin (75 mg/m2, day 1-3) and 5-fluorouracil (5-FU; 1000mg/m2/day,civ, day 1-4) for 2 cycles every 3 weeks. * Endostar: recombinant human endostatin (15mg/m2/d, civ, d1-7) is given 3 days before the chemotherapy every 3 weeks, total of two cycles during chemoradiotherapy course.
- interventionNames
- Combination Product: Chemoradiotherapy+ Endostar
Primary outcomes (2)
- measure
- 3-year Disease-free survival
- timeFrame
- 3 years
- description
- From date of surgery until the date of first documented local-regional progression or distant metastasis (determined by CT or MRI scan and/or biopsy) or death (from any cause) assessed up to three years.
- measure
- Acute toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Aged between 18 and 70 years. * Histologically confirmed adenocarcinoma or squamous cervical carcinomas. * Chest CT scan and ultrasound must be done prior to surgery as to rule out distant metastasis. * Operable patients with clinical diagnosis of FIGO stage IB-IIA cervical cancer. * Complete radical hysterectomy of cervical cancer is mandatory. All gross diseases must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor. Para-aortic lymph node sampling is performed according to gynaecologist decision. * Patients with one of these risk factors:positive pelvic nodes, parametrial invasion, positive surgical margin.OR patients with at least two of following risk factors: tumor size≥4cm,lymphovascular space invasion,stromal invasion≥1/2. * Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group). * Adequate organ function is needed, including cardio-respiratory, hepato-renal and hematological reserves: Absolute neutrophil count (ANC)≥1.5×109/L;Platelet count≥100×109/L; ASAT\&ALST\<1.5 times upper limit of normal (ULN) (With hepatic metastases, ASAT\&ALST\<5.0 times upper limit of normal);Bilirubin \<1.5 times ULN;Creatinine≤1.25×ULN or Creatinine clearance≥50 mL/min. * Signed written informed consent prior to study entry. Exclusion Criteria: * Previous radiation or chemotherapy treatment or major pelvic surgery. * Patients with distant metastasis confirmed by imaging or pathology. * Other uncured malignant tumors in the past five years, except the cured skin basal cell carcinoma and breast carcinoma in situ. * Any prior anticancer therapy. * Unable to tolerate postoperative concurrent chemoradiotherapy. * Patients with evidence of being allergic to fluorouracil, cisplatin or Endostar. * Patients with serious comorbidity that might potentially influence the practice of protocol, including severe infection, myocardial infarction, severe arrhythmia, severe cerebrovascular disease, severe mental disorder, etc. * Patients with Heart related adverse events or thrombotic events in the past 6 months. * Patients with hepatitis B, hepatitis C and human immunodeficiency virus (HIV) or any other active viral infections. * Participate in other clinical researchers. * The estimated survival\<3 months;
References
Publications (0)
Data not yet available
No reference posted for this study.