Intensive nutrition during conversion therapy to enable surgery for locally advanced unresectable esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 randomized study enrolls patients with locally advanced unresectable esophageal squamous cell carcinoma who are receiving PD-1 inhibitor combined with chemotherapy. Participants are randomly assigned to intensive enteral nutritional support or standard nutritional care during conversion therapy. After systemic therapy, patients planned for surgery undergo esophagectomy with lymph node dissection and the primary endpoint is pathological complete response (pCR) at surgery. Safety, treatment tolerance, and other clinical outcomes will also be tracked.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Pathologically confirmed Esophageal Squamous Cell Carcinoma (ESCC). Aged 18-80 years, regardless of gender. ECOG Performance Status (PS) 0-2, and weight loss \< 10% within the past 6 months.

Confirmed locally advanced unresectable ESCC according to NCCN Guidelines (Version 2026.1).

Planned to receive surgery after completion of conversion therapy, with no surgical contraindications.

Treatment-naive: No prior anti-tumor therapy for ESCC, including radiotherapy, chemotherapy, or surgery.

Presence of measurable lesion(s) according to RECIST 1.1. Expected survival ≥ 3 months. Able to swallow and tolerate oral medications. Adequate organ function (blood counts, biochemistry, and coagulation parameters meeting protocol requirements).

Women of childbearing age and men must agree to use effective contraception during the study and for 6 months after completion.

Voluntary participation with signed informed consent and good compliance.

Exclusion Criteria:

Presence of esophageal-mediastinal fistula and/or tracheoesophageal fistula, or tumor invasion of major vessels with risk of fatal hemorrhage.

History of other malignant tumors within the past 5 years. Current or prior use of immunosuppressants or systemic steroids (\>10 mg/day prednisone equivalent) within 2 weeks prior to first dose.

Active autoimmune disease or history of autoimmune disease requiring systemic treatment.

Known immunodeficiency history, including HIV infection, organ transplant, or bone marrow transplant.

Uncontrolled concurrent diseases (e.g., uncontrolled hypertension, unstable angina, recent myocardial infarction, or severe infections).

Active tuberculosis (TB) or history of TB without standardized treatment. Active Hepatitis B (HBV) or Hepatitis C (HCV) infection. Complete inability to take oral enteral nutrition due to esophageal stenosis. History or current presence of interstitial pneumonia or interstitial lung disease.

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.

Significant gastrointestinal disorders with severe diarrhea (CTCAE \> Grade 2). Pregnant or lactating women. Participation in other clinical trials within 30 days prior to enrollment.

Where it's running

• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Zhenyu Ding, PhD
• Email: dingzhenyu@scu.edu.cn
• Phone: +86-189-8060-1957

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy

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• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

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• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

  Recruiting Phase 2 First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shannxi · NCT07796113

• SKB500 combinations for esophageal squamous cell carcinoma

  This study tests SKB500 combined with other drugs to see if it is safe and shows early signs of activity in adults with unresectable or metastatic esophageal squamous cell carcinoma who have limited prior treatment.

  Recruiting at 24 sites Phase 2 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Changchun and 23 other locations · NCT07700667

• Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma

  This study tests whether adding cardonilizumab to preoperative chemotherapy (versus chemoradiotherapy) helps patients with locally advanced ESCC have a better chance at complete tumor removal and longer survival.

  Recruiting Phase 2 Tongji Hospital · Wuhan, Hubei · NCT07699185

• Surgery or chemoradiotherapy after neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma

  In people with locally advanced ESCC who respond to neoadjuvant immunochemotherapy, this study tests whether organ preservation with treatment other than surgery can be as effective as radical esophagectomy.

  Recruiting Phase 3 Henan Cancer Hospital · Zhengzhou, Henan · NCT07629817

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.