Clinical trial · Interventional
Efficacy and Safety of TPF Induction Chemotherapy for Borderline-resectable Esophageal Squamous Cell Carcinoma
Paclitaxel In Combination With Cisplatin and 5-fluorouracil(TPF) Induction Chemotherapy for Locally Advanced Borderline-resectable Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial
NCT02976909CI-TRIAL-00064043completedPhase 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 trial studies the efficacy and safty of paclitaxel in combination with cisplatin and 5-fluorouracil(TPF) induction chemotherapy for locally advanced borderline-resectable 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 |
|---|---|---|---|
| Paclitaxel+Cisplatin+5fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel+Cisplatin+5fluorouracil
- description
- Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.
- interventionNames
- Drug: Paclitaxel+Cisplatin+5fluorouracil
Primary outcomes (1)
- measure
- R0 resection rate
- timeFrame
- following resection for up to 36 months
- description
- The rate of R0 resection
Secondary outcomes (4)
- measure
- pathologic complete response rate
- timeFrame
- following resection for up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients should be voluntary to the trial and provide with signed informed consent. 2. Male or female patients, age:18-70 years old 3. Confirmed by histology of thoracic esophageal squamous cell carcinoma without metastasis and diagnosed as boundary resectable by Multidisciplinary consultation, including cT4 and/or bulky lymphadenopathy that may invade nearby organs(such as the great vessels, trachea and heart, etc.) 4. Measurable or unmeasurable lesions according the RECIST 1.1 criteria. 5. No previous chemotherapy or radiotherapy. 6. Life expectancy ≥ 3 months. 7. ECOG PS 0-1. 8. Blood routine within 7 days:Hb ≥9g/L,NE ≥1.5×109/L,PLT ≥100×109/L; 9. Hepatic and renal function:TB \<1.5 UNL, Cr\< 1.5× UNL, AST / ALT \< 2.5× UNL, ALP \< 5.0 × UNL。 10. No severe complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever \> 38 ℃ 11. Fertile patients should take effective contraceptive measures. 12. Patients should have good compliance and cooperate with the evaluation of efficacy and adverse events and follow-ups according to the research plan. Exclusion Criteria: 1. Cervical esophageal carcinoma. 2. Known severe hypersensitivity to drugs in the regimen. 3. 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). 4. Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension. 5. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction. 6. Evidence of active infection or active epidemic disease. 7. Psychiatric illness that would prevent the patient from giving informed consent 8. Pregnant or lactating women.
References
Publications (2)
- DERIVEDWu JD, Wang ZQ, Li QQ, Li ZC, Ren C, Wang DS, Chen JY, Tan Q, Li YH, Yang H. A 3-Year Survival Update from a Phase 2 Study of Paclitaxel Plus Cisplatin and 5-Fuorouracil Induction Chemotherapy for Locally Advanced Borderline-Resectable Esophageal Squamous Cell Carcinoma: The NEOCRTEC-1601 Clinical Trial. Ann Surg Oncol. 2024 Feb;31(2):838-846. doi: 10.1245/s10434-023-14513-0. Epub 2023 Nov 2. PMID 37919448
- DERIVEDWang Z, Hu M, Hu Y, Li Q, Wu J, Fong WP, Ren C, Wang D, Tan Q, Yang H, Li Y. Paclitaxel plus cisplatin and 5-fluorouracil induction chemotherapy for locally advanced borderline-resectable esophageal squamous cell carcinoma: a phase II clinical trial. Esophagus. 2022 Jan;19(1):120-128. doi: 10.1007/s10388-021-00864-8. Epub 2021 Jul 28. PMID 34319435