Clinical trial · Interventional
Chemoradiotherapy in Unresectable Esophageal Cancer
A Phase I/II Study of Chemoradiotherapy Using Albumin-Bound Paclitaxel and Cisplatin in Unresectable Esophageal Squamous Cell Carcinomas Based on Nutritional Risk Screening Score (NRS2002)
NCT04278287CI-TRIAL-00083735recruitingPhase 1 / Phase 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 I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Albumin-bound Paxlitaxel | — | UNRESOLVED | — |
| Chemoradiotherapy | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Unresectable Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin-Bound Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy
- description
- Chemoradiotherapy arm receives intensity-modulated radiation therapy, volume modulated arc therapy or tomotherapy concurrently with albumin-bound paclitaxel and cisplatin (weekly intravenous infusion in 5-6 weeks).
- interventionNames
- Radiation: Radiotherapy
- Drug: Albumin-Bound Paclitaxel
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Local control rate
- timeFrame
- 1 year from the start of treatment to tumor recurrence
- description
- Control rate of primary esophageal cancer and metastatic lymph nodes within irradiation fields
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18\~75 years * Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis) * Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences * ECOG PS score: 0\~1 * NRS2002 score \<3 * Estimated survival time ≥3 months * Normal organ and marrow function as defined below: Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit * Informed consent Exclusion Criteria: * With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc * Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer * Existing active infection such as active tuberculosis and hepatitis * History of myocardial infarction within the past 6 months or history of ventricular arrhythmia * Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness * History of allergic reactions attributed to paclitaxel, albumin or cisplatin * Participation in other clinical trials currently or within 4 weeks of selection * Pregnant or lactating females
References
Publications (0)
Data not yet available
No reference posted for this study.