Clinical trial · Interventional
Study of Endostar Combined With TP Regimen for Esophageal Cancer
A Clinical Study of Endostar Combined With TP Regimen for Chemoradiotherapy in Esophageal Cancer
NCT04164797CI-TRIAL-00041913unknownPhase 4ClinicalTrials.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)
a randomized controlled trial of endostar combined with TP regimen(liposomal paclitaxel-carboplatin) for chemoradiotherapy in esophageal squamous cell carcinoma(Ⅱ-Ⅲ)
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 |
|---|---|---|---|
| Patients With Esophageal Cancer(Ⅱ-Ⅲ) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoradiotherapy | Other | — | UNRESOLVED |
| endostar+chemoradiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- endostar : 7.5mg/m2/d,continuous infusion for 5 days in week 1、3、5、7, chemotherapy:paclitaxel liposomes 50mg / m2, ivgtt, d8, 15, 22, 29, 36, carboplatin AUC 2, ivgtt d8, 15, 22, 29, 36 radiotherapy:EBRT,61.2 Gy,1.8Gy/d
- interventionNames
- Drug: endostar+chemoradiotherapy
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- chemotherapy:paclitaxel liposomes 50mg / m2, ivgtt, d8, 15, 22, 29, 36, carboplatin AUC 2, ivgtt d8, 15, 22, 29, 36 radiotherapy:EBRT,61.2 Gy,1.8Gy/d
- interventionNames
- Other: chemoradiotherapy
Primary outcomes (2)
- measure
- objective response rate(ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 to 75 years; 2. Pathology confirmed as esophageal squamous cell carcinoma and Clinical stage is II-III; 3. Initial treatment, No surgery history; 4. ECOG 0\~2; 5. Expected survival \>=3 months; 6. All the patients should have target lesions that are measurable and evaluable; 7. Should be able to consume liquid diet, no esophageal perforation symptoms, no distant metastases; 8. The main organ function is normal, which meets the following criteria: (1) The standard of blood test should be met (14 days without blood transfusion and blood products, no G-CSF and other hematopoietic stimulation factor correction): Hb\>=100g/L;ANC\>=1.5x10\^9/L;PLT\>=100x10\^9/L; (2) Biochemical inspection shall meet the following criteria: TBIL \< 1.5 ULN; ALT and AST \< 2.0 ULN.Serum Cr is less than 1.5 ULN or endogenous creatinine clearance rate \> 50 ml/min (the Cockcroft Gault formula); (3) Pulmonary function FEV1 \>=1 L or \>50% of corresponding value of normal people; 9\. Female during the reproductive period should be ensured contraception during the study period; 10. Participants voluntarily joined the study, signed informed consent, and had good compliance and follow-up. Exclusion Criteria: 1. Patients who do not meet the pathological type of the inclusion criteria and the primary site; 2. Allergic to recombinant endostar, carboplatin, paclitaxel, and contrast agents; 3. Have a distant metastasis; 4. The primary focal tumors or lymph node already had a surgical treatment (except for biopsy), chemoradiotherapy or targeted therapy; 5. Patient who suffered from other malignant tumor; 6. Subject with severe pulmonary and cardiopathic disease history; 7. Pregnant woman or Lactating Women and Women in productive age who refuse take contraception in observation period; 8. Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct; 9. Received other medicine trials in past 4 weeks; 10. Refuse or incapable to sign the informed consent form of participating this trial; 11. The researchers judged other conditions that could affect clinical research and the results of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.