Lymphatic-sparing short-course radiotherapy with chemo-immunotherapy before surgery for locally advanced ESCC

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 is a prospective, single-arm phase II trial enrolling adults with resectable, locally advanced thoracic ESCC. Participants receive three cycles of camrelizumab plus chemotherapy, followed by a short course of radiotherapy (25 Gy in 5 fractions) targeting the tumor and involved lymph nodes while sparing elective lymphatics. Surgery (McKeown esophagectomy) is planned 4-6 weeks after neoadjuvant therapy, with pathologic complete response (ypT0N0) as the primary endpoint. The study uses a Simon optimal two-stage design with a planned total of about 33 evaluable patients to assess feasibility and safety. Eligibility includes treatment-naive adults, specific AJCC stage, measurable disease, and adequate organ function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent before enrollment.
* Age 18 to 75 years, any sex.
* Treatment-naive esophageal squamous cell carcinoma confirmed by pathology and PET-CT.
* Clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (stage II/III according to the AJCC 9th edition).
* Disease assessed as amenable to R0 surgical resection before treatment.
* At least one measurable lesion according to RECIST v1.1.
* ECOG performance status 0-1.
* Adequate organ function: absolute neutrophil count ≥1,500/mm³; platelets ≥100,000/mm³; hemoglobin ≥9 g/dL; serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min; bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; no blood components or hematopoietic growth factors within 14 days.
* For women of childbearing potential: medically accepted contraception during treatment and for 3 months afterward; negative serum or urine HCG within 7 days before enrollment; not breastfeeding.
* For men who are not surgically sterile: agreement to use medically accepted contraception with their partner during treatment and for 3 months afterward.
* Willingness to participate and comply with safety and survival follow-up.

Exclusion Criteria:

* Prior radiotherapy, chemotherapy, prolonged/high-dose corticosteroid therapy, surgery, or molecular targeted therapy.
* Previous or concurrent other malignancy.
* Prior PD-1/PD-L1 therapy; known allergy to macromolecular protein preparations or any component of PD-1 therapy.
* Active autoimmune disease or relevant autoimmune disease history as specified in the protocol.
* Immunosuppressive agents for immunosuppression within 2 weeks before enrollment.
* Symptomatic pleural or peritoneal effusion requiring therapeutic puncture or drainage.
* Poorly controlled clinically significant cardiac disease as specified in the protocol.
* Abnormal coagulation with bleeding tendency or thrombolytic/anticoagulant therapy.
* Recent gastrointestinal conditions associated with bleeding or perforation risk.
* Severe bleeding within 3 months, hemoptysis within 4 weeks, or thromboembolic event within 12 months according to protocol thresholds.
* Active infection or unexplained fever \>38.5°C during screening or before first dose.
* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment.
* History/current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction.
* Congenital/acquired immunodeficiency including HIV infection, or active hepatitis outside protocol-defined limits.
* Participation in another clinical study or completion of a previous clinical study within 1 month; anticipated need for other systemic anticancer therapy.
* Live vaccine within 4 weeks before study treatment or anticipated during the study.
* Known history of psychotropic drug abuse, alcohol abuse, or illicit drug abuse.
* Unable or unwilling to bear self-paid portions of study-related examinations or treatment.
* Any other condition considered by the investigator to compromise participant safety, study completion, or data/sample collection.

Where it's running

• The Sixth Affiliated Hospital, Sun Yat-sen University
  Guanzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Hongying Liao MD, Professor / Chief Physician, MD and PhD
• Email: liaohy2@mail.sysu.edu.cn
• Phone: +86-020-35919121

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

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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.