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DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR/PR After nCI | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

Definitive Concurrent Chemoradiotherapy Versus Surgery in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (ESCC) Who Achieve Complete or Partial Response After Neoadjuvant Camrelizumab Combined With Chemotherapy: A Two-arm Phase II Clinical Study (SORT Trial)

NCT07162506•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This is a single-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 camrelizumab combined with chemotherapy. A total of 120 eligible subjects will be enrolled. Patients with cCR/PR after 2 cycles of induction chemoimmunotherapy (camrelizumab + nab-paclitaxel + carboplatin) 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Volunteered to participate, cooperated with follow-up visits.
•2. Aged 18 - 75 years (inclusive), male or female.
•3. 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 cycles of camrelizumab combined with nab-paclitaxel and carboplatin.
•4. Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);
•5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
•6. Estimated survival time ≥ 3 months.
•7. The function of major organs meets the following requirements:
•1. Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L;
•2. Platelets ≥ 80×10\^9/L;
•3. Hemoglobin ≥ 9g/dL;
+5 more criteria

Exclusion Criteria

•1. Surgery for esophageal cancer;
•2. Esophageal fistulae due to infiltration of the primary tumor；
•3. Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation;
•4. Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
•5. Major surgery or severe trauma within 4 weeks prior to first use of study drug;
•6. Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
•7. Received or receiving any of the following treatments in the past:
•1. Anti-PD-1 (except for camrelizumab) or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy or targeted therapy;
•2. Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;
•3. 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;
+12 more criteria

Locations (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

August 1, 2025

Primary Completion Date

August 30, 2027

Completion Date

August 30, 2030

Last Updated

February 4, 2026

Enrollment

120

ESTIMATED participants

Conditions

Esophageal Cancer

Interventions

Surgery

PROCEDURE

Radiotherapy

RADIATION

Chemotherapy

DRUG

Contacts

Wencheng Zhang, M.D.

CONTACT

02223340123 zhangwencheng@tjmuch.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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