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

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Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 33 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

esophageal squamous cell carcinoma Pathologic Complete Response

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guanzhou, Guangdong, 510655, China

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