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Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC

ConditionsEsophageal Squamous Cell CarcinomaLocally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSichuan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • PD-1 Inhibitor plus Chemotherapy

    Drug

    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

    Dietary supplement

    Oral enteral nutritional preparation taken twice daily for 2 cycles (each cycle is 3 weeks).

  • Esophagectomy with lymph node dissection

    Procedure/Surgery

    Surgical resection of the esophagus and lymph node dissection, planned 4-6 weeks after the completion of conversion therapy.

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: Intensive Nutritional Support GroupExperimental treatment 3 interventions
Group B: Standard Nutritional Support GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Pathological 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).

Secondary outcomes

1

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.
2

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).
3

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

West China Hospital

Sponsor institution

Source ClinicalTrials.gov
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