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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
PD-1 inhibitor combined with chemotherapy (Paclitaxel or Albumin-bound paclitaxel plus Cisplatin or Carboplatin), administered once every 3 weeks for 2 cycles.
Oral enteral nutritional preparation taken twice daily for 2 cycles (each cycle is 3 weeks).
Surgical resection of the esophagus and lymph node dissection, planned 4-6 weeks after the completion of conversion therapy.
West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGPathological Complete Response (pCR) Rate
Defined as the absence of residual viable tumor cells in the primary tumor bed and all sampled lymph nodes (ypT0N0) according to the Mandard regression criteria, as evaluated by a blinded Independent Review Committee (BIRC).
Time frame: At the time of surgery (approximately 4-6 weeks after the completion of conversion therapy).
Event-Free Survival (EFS)
The time from randomization to the date of first documentation of disease progression, recurrence after surgery, or death from any cause.
Time frame: From randomization up to 2 years.
Major Pathological Response (MPR) Rate
Defined as ≤ 10% residual viable tumor cells in the primary tumor bed
Time frame: At the time of surgery (approximately 4-6 weeks after conversion therapy).
Objective Response Rate (ORR)
The percentage of participants with a complete response (CR) or partial response (PR) as per RECIST v1.1 before surgery.
Time frame: Approximately 2 months (after completion of 2 cycles of conversion therapy).
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