💬In plain words
What the trial is, and whether it could suit you
This prospective, single-arm phase II study will evaluate the efficacy and safety of lymphatic-drainage-sparing short-course radiotherapy combined with camrelizumab and nab-paclitaxel/carboplatin as neoadjuvant treatment for patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma. Participants will receive three 3-week cycles of camrelizumab plus chemotherapy, with 25 Gy in 5 fractions of short-course radiotherapy delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared. Definitive McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy. The primary endpoint is pathologic complete response (ypT0N0).
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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