Node-Sparing Short-Course radiotherapy (25 Gy/5 fractions) combined with chemoimmunotherapy as neoadjuvant treatment for locally advanced esophageal squamous cell Carcinoma:A prospective Single-Arm, phase II study
NCT ID NCT07808853
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
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).
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITINGGuanzhou, Guangdong, 510655, China
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