Intestinal Low-Dose Radiotherapy plus Immunochemotherapy to Convert Borderline Resectable or 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 interventional trial investigates a multimodal approach for locally advanced esophageal squamous cell carcinoma. Participants receive intestinal low-dose radiotherapy (1 Gy) combined with PD-1/PD-L1 inhibitors, chemotherapy, and planned surgery if the cancer becomes resectable. The goal is to convert unresectable or borderline resectable disease into candidates for curative surgery, potentially improving survival and quality of life. Eligibility includes adults 18–75 with thoracic ESCC, adequate organ function, and no prior anti-cancer therapy. The study is led by Chuangzhen Chen with BeOne Medicines, at Cancer Hospital, Shantou University Medical College, in Shantou, Guangdong.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients voluntarily enroll in this study, sign an informed consent form, and demonstrate good compliance.
2. Age ≥18 years and ≤75 years; both sexes are eligible.
3. ECOG performance status score of 0-1.
4. Pathologically confirmed esophageal squamous cell carcinoma (ESCC) prior to surgery.
5. Thoracic esophageal cancer.
6. Unresectable lesions, defined as: T4 stage; Borderline resectable T3 disease, in which imaging cannot exclude invasion of adjacent organs or structures, such as the trachea, bronchi, or aorta; T3 disease with supraclavicular lymph node metastasis; or clinically confirmed unresectable disease by the surgeon.
7. No prior history of anti-tumor treatment, including chemotherapy, hormonal therapy, radiotherapy, or immunotherapy.
8. Baseline laboratory requirements (within 7 days prior to enrollment):

   Hematology:
   1. Hb≥90 g/L (no transfusion within 14 days)
   2. NEUT ≥1.5×10⁹/L
   3. PLT ≥100×10⁹/L
   4. WBC≥3×10⁹/L

   Biochemistry:
   1. ALT and AST≤2.5×ULN
   2. TBIL≤1.5×ULN
   3. SCr≤1.5×ULN; or CrCl≥60 mL/min Coagulation: APTT, INR, and PT≤1.5×ULN Thyroid function: TSH≤ULN (if abnormal, FT3/FT4 levels should also be considered; eligible if FT3/FT4 are normal) Echocardiography: LVEF≥50%
9. Female subjects need to agree to use contraception during the study and for 6 months post-study; serum pregnancy test negative within 7 days prior to enrollment; non-lactating. Male subjects must agree to use contraception during the study and for 6 months post-study.
10. No psychological, familial, social, or geographical factors that may impair protocol adherence.
11. Other parameters meet general clinical trial enrollment criteria.
12. The subject or authorized representative has read, fully understands the patient information sheet, and signed the informed consent form.

Exclusion Criteria:

1. Patients with distant metastases other than supraclavicular lymph node metastases.
2. Presence or high risk of esophageal perforation.
3. Patients with contraindications to radiotherapy or immune checkpoint inhibitor (ICI) therapy.
4. Subjects with active, uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.
5. Respiratory depression, airway obstruction, or tissue hypoxia.
6. Severe cardiac disease (i.e., NYHA functional class II or higher).
7. Markedly abnormal liver or kidney function (i.e., indicators \>3 times the upper limit of normal).
8. Active hepatitis B, hepatitis C, HIV, or syphilis.
9. Active brain disease or central nervous system/meningeal metastases with significant symptoms, or impaired decision-making capacity.
10. Hypersensitivity to drugs included in the trial.
11. Drug and/or alcohol abuse.
12. Pregnant or lactating women.
13. Concurrent participation in another therapeutic clinical trial.
14. Major surgical procedure within 30 days prior to enrollment.
15. Use of antibiotics, antifungals, antivirals, or antiparasitics within 4 weeks prior to registration.

Where it's running

• Cancer Hospital, Shantou University Medical College
  Shantou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Chuangzhen Chen
• Email: czchen2@stu.edu.cn
• Phone: +86 13923995569

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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.