Trials / Recruiting
RecruitingNCT07519486
Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC
A Prospective Randomized Controlled Clinical Trial of Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- Sponsor
- Sichuan University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Malnutrition is highly prevalent in patients with upper gastrointestinal tumors, which may negatively impact treatment tolerance and anti-tumor immune responses. This study aims to evaluate the efficacy and safety of intensive enteral nutritional support in patients with locally advanced unresectable esophageal squamous cell carcinoma (ESCC) undergoing conversion therapy. Participants receiving PD-1 inhibitors combined with chemotherapy will be randomly assigned to either intensive nutritional support or standard care. The primary goal is to determine if intensive nutritional support can improve the pathological complete response (pCR) rate after subsequent surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PD-1 Inhibitor plus Chemotherapy | PD-1 inhibitor combined with chemotherapy (Paclitaxel or Albumin-bound paclitaxel plus Cisplatin or Carboplatin), administered once every 3 weeks for 2 cycles. |
| DIETARY_SUPPLEMENT | Oral Enteral Nutritional Preparation | Oral enteral nutritional preparation taken twice daily for 2 cycles (each cycle is 3 weeks). |
| PROCEDURE | Esophagectomy with lymph node dissection | Surgical resection of the esophagus and lymph node dissection, planned 4-6 weeks after the completion of conversion therapy. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2027-09-01
- Completion
- 2028-03-01
- First posted
- 2026-04-09
- Last updated
- 2026-04-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07519486. Inclusion in this directory is not an endorsement.