Clinical trial · Interventional
Endostar Combined With Paclitaxel and Nedaplatin in Treating Patients With Recurrent or Metastatic Esophageal Cancer
A Phase II Trial of Recombinant Human Endostatin Injection (Endostar) Combined With Paclitaxel and Nedaplatin as First-line Therapy in Treating Patients With Recurrent or Metastatic Esophageal Cancer
NCT02350517CI-TRIAL-00064029completedPhase 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)
This phase Ⅱ study was designed to evaluate the efficacy and safety of endostar combined with paclitaxel and nedaplatin as first-line therapy in treating patients with recurrent or metastatic esophageal squamous cell 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 |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel+Nedaplatin+Endostar | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel+Nedaplatin+Endostar
- description
- Patients will receive chemotherapy every 3 weeks: Paclitaxel 175mg/m2 IV over 3 hours on Day 4; Nedaplatin 80mg/m2 IV over 1 hours on Day 4; Endostar 3mg/day for 14 days continuous infusion from Day 1 to Day 14.
- interventionNames
- Drug: Paclitaxel+Nedaplatin+Endostar
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (4)
- measure
- Overall survival
- timeFrame
- From the date of first drug administration until the date of death, assessed up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients have provided a signed Informed Consent Form * Age: 18-75 years old * Histologically confirmed diagnosis of recurrent or metastatic or unresectable advanced esophageal squamous cell carcinoma * Patients have neither received any palliative chemotherapy nor adjuvant chemotherapy or concurrent chemotherapy with taxane based drugs or large doses cisplatin (cumulative dose ≥ 300mg/m2). The time from the last adjuvant or concurrent chemotherapy to relapse or metastasis should more than 6 months. * Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria; Targeted lesions should not include primary esophageal lesions * Life expectancy ≥ 3 months * Karnofsky score ≥70 * Patient has adequate bone marrow and organ function * Leukocyte ≥ 3.5 x 10\^9/L * eAbsolute Neutrophil Count (ANC) ≥ 1.8 x 10\^9/L * Platelets ≥ 90 x 10\^9/L * Hemoglobin ≥ 10g/L * Patient has adequate liver function * AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) * Serum bilirubin ≤ 1.2 x ULN * Creatinine ≤ 1.2 times ULN * Alkaline phosphatase ≤ 5.0 times ULN * No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever \> 38 ℃. * Patients with effective contraceptive measures * Expect good compliance Exclusion Criteria: * Patients have received radiotherapy in 3 months. * Patients with relapse recurrent or metastatic lesions in radiated area. * Patient has received previous treatment with VEGF inhibitors * Known severe hypersensitivity to the drugs in the experimental chemotherapy or any of the excipients of these products * Patients without measureable lesions * Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases * Patients with chronic diarrhea * Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ * psychiatric illness including CNS metastases that would prevent the patient from giving informed consent * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.