DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR/PR After nCI

NCT07162506 | Recruiting Phase 2

• 1 other identifier: E20260592
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, Phase II clinical study aiming to evaluate the efficacy, safety, and organ preservation feasibility of definitive concurrent chemoradiotherapy versus surgery in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) who achieve clinical complete response/partial response (cCR/PR) after neoadjuvant chemo-immunotherapy. A total of 120 eligible subjects will be enrolled. Patients with cCR/PR after 2-3 cycles of neoadjuvant chemo-immunotherapy will be grouped based on personal willing: the control group (n=60) will receive radical esophagectomy + mediastinal lymph node dissection; the experimental group (n=60) will receive definitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy/28f; chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles). All the patients will receive camrelizumab maintenance therapy (200mg q21d) up to 1 year.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease-Free Survival

  up to 3 years

Secondary Outcomes (7)

• OS

  up to 3 years

• LRR

  up to 3 years

• R0 resection

  up to 3 years

• AEs

  up to 3 years

• QoL

  up to 3 years

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Radical esophagectomy + mediastinal lymph node dissection

Procedure: Surgery; Drug: Immunotherapy

DCRT

EXPERIMENTAL

Definitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy/28f; chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles)

Radiation: Radiotherapy; Drug: Chemotherapy; Drug: Immunotherapy

Interventions

Surgery PROCEDURE

Radical esophagectomy + mediastinal lymph node dissection

Surgery

Radiotherapy RADIATION

Radiotherapy: 50.4 Gy/28f

DCRT

Chemotherapy DRUG

Chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles

DCRT

Immunotherapy DRUG

Camrelizumab maintenance therapy (200mg q21d) up to 1 year.

DCRT; Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteered to participate, cooperated with follow-up visits.
• Aged 18 - 75 years (inclusive), male or female.
• Histologically confirmed locally advanced resectable ESCC, clinically staged as Stage II - IVa (cT1N1-3M0, cT2-4aN0-3M0 before treatment; 8th AJCC), and achieve cCR/PR after 2-3 cycles of platinum-based chemotherapy combined with anti-PD-1 or PD-L1 monoclonal antibodies.
• Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Estimated survival time ≥ 3 months.
• The function of major organs meets the following requirements:
• Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L;
• Platelets ≥ 80×10\^9/L;
• Hemoglobin ≥ 9g/dL;
• Serum albumin ≥ 2.8g/dL;
• Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or ALP ≤ 2.5 × ULN;
• Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL/min;
• International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5× ULN (subjects on stable doses of anticoagulation therapy, such as low molecular weight heparin or warfarin, and with INR within the expected therapeutic range of the anticoagulant can be screened);
• Comprehensive baseline staging evaluation prior to induction chemo-immunotherapy, including esophagogastroduodenoscopy (with biopsy) and/or endoscopic ultrasonography (EUS), contrast-enhanced CT of the neck, chest, and upper abdomen (with or without PET-CT), magnetic resonance imaging (MRI) without MRI contraindications, and upper gastrointestinal contrast.

You may not qualify if:

• Surgery for esophageal cancer;
• Esophageal fistulae due to infiltration of the primary tumor；
• Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation;
• Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
• Major surgery or severe trauma within 4 weeks prior to first use of study drug;
• Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
• Received or receiving any of the following treatments in the past:
• Radiotherapy or targeted therapy;
• Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;
• Systemic treatment with corticosteroids (\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment (except for the use of corticosteroids for local inflammation of the esophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor. Inhaled or topical steroids and adrenocorticotropic hormone replacement at doses \>10mg/day prednisone efficacy dose are permitted if the patient does not have active autoimmune disease;
• Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;
• Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;
• Diagnosis of immunodeficiency, including positive HIV test, other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;
• Diagnosis of uncontrolled cardiac clinical symptoms or disease such as: a. NYHA II or above heart failure; b. unstable angina; c. myocardial infarction within 1 year; d. clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
• Severe infections (CTCAE \> grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Shanxi Province Cancer Hospital: collaborator
• Sichuan Province Cancer Hospital: collaborator
• Henan Province Cancer Hospital: collaborator

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Surgical Procedures, Operative; Radiotherapy; Drug Therapy; Immunotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy

Study Officials

• Wencheng Zhang, M.D.

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Xiaofeng Duan, M.D.

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wencheng Zhang, M.D.

CONTACT

02223340123; zhangwencheng@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Prof. in the department of radiation oncology

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2030
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)