Clinical trial · Interventional
A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma
NCT03857763CI-TRIAL-00037361unknownPhase 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)
The purpose of this study is to assess the efficacy and safety of apatinib plus concurrent neoadjuvant chemoradiotherapy in patients with esophageal squamous cell carcinoma.
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 |
|---|---|---|---|
| Apatinib,Paclitaxel,Cisplatin,RT | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib+Paclitaxel+Cisplatin+RT
- description
- Apatinib:250mg,po,qd, d1-35; Paclitaxel:50mg/m2 iv, d1,8,15,22,29; Cisplatin: 30mg/m2 iv, d1,8,15,22,29; Radiotherapy:41.4Gy/23f , 1.8Gy/f,5 f/w
- interventionNames
- Combination Product: Apatinib,Paclitaxel,Cisplatin,RT
Primary outcomes (1)
- measure
- The pathological complete response rate(pCR)
- timeFrame
- within 3 weeks after surgery
- description
- The lesion disappeared completely by pathology
Secondary outcomes (4)
- measure
- R0-resection rate
- timeFrame
- within 3 weeks after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age:18 to 70 years old (man or female); 2. Pathologically diagnosed with esophageal squamous cell carcinoma; 3. Patients with Stage for Ⅱ-Ⅲ(T2-4N0/+M0) (According to transesophageal ultrasonography; 4. Patients with measurable lesions(According to the criteria in RECIST1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Life expectancy greater than or equal to 3 months; 7. Major organ function has to meet the following certeria: (1) For results of blood routine test 1. HB≥80g/L; 2. ANC≥1.5×109/L; 3. PLT≥90×109/L; (2) For results of blood biochemical test a) ALT and AST≤2.5×ULN; b) TBIL\<1.5×ULN; c) Serum creatinine ≤1.5×ULN; 8. Doctors believe that treatment can bring benefits to patients; 9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up. Exclusion Criteria: 1. Have received prior treatment with chemotherapy or radiotherapy; 2. Have high blood pressure and antihypertensive drug treatment can not control; 3. Patients with severe cardiovascular disease ; 4. Accompanied by esophageal perforation and esophagotracheal fistula; 5. Patients with active bleeding or bleeding tendency; 6. Pregnant or lactating women; 7. The researchers think inappropriate.
References
Publications (0)
Data not yet available
No reference posted for this study.