Definitive chemoradiotherapy versus surgery for resectable esophageal squamous cell carcinoma after a good response to preoperative chemo-immunotherapy
Official title: Surgery or Definitive Chemoradiotherapy in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma Achieving Clinical Response After Neoadjuvant Chemoimmunotherapy: A Prospective, Preference-Based, Comparative Two-Cohort Phase II Trial (SORT Trial)
Run by Tianjin Medical University Cancer Institute and Hospital · NCT07162506 · Data updated 2026-11-12
This study will test whether definitive concurrent chemoradiotherapy can allow people with resectable esophageal squamous cell carcinoma who respond well after two cycles of chemo-immunotherapy to avoid surgery while maintaining disease control.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | camrelizumab, prednisone, chemotherapy, immunotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | August 30, 2027 |
| Study ends | August 30, 2030 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07162506 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 years with histologically confirmed, locally advanced yet resectable esophageal squamous cell carcinoma (clinical Stage II–IVa) who achieve clinical complete or partial response after two cycles of platinum-based chemo plus anti–PD-1/PD-L1 therapy, with ECOG 0–1 and adequate organ function are eligible.
✕Probably not a fit
Patients who do not achieve cCR/PR after neoadjuvant chemo‑immunotherapy, have unresectable disease, poor performance status, major organ dysfunction, or contraindications to radiotherapy/chemotherapy/immunotherapy are unlikely to benefit from the organ-preserving approach tested here.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter Phase II study enrolls 120 patients with locally advanced resectable esophageal squamous cell carcinoma who achieve a clinical complete or partial response after two cycles of platinum-based chemo combined with an anti–PD-1/PD-L1 agent. Patients choose between radical esophagectomy with mediastinal lymph node dissection (control, n=60) or definitive concurrent chemoradiotherapy (experimental, n=60) consisting of 50.4 Gy in 28 fractions with two cycles of nab‑paclitaxel plus carboplatin. All participants receive camrelizumab maintenance every 21 days for up to one year. The trial measures organ preservation feasibility, safety, and oncologic outcomes in the two groups.
Why it matters
Potential benefit: If successful, the approach could allow some patients to preserve their esophagus and avoid the risks and recovery of major surgery while keeping similar cancer control.
How similar studies have gone: Previous trials of definitive chemoradiotherapy and recent chemo‑immunotherapy combinations in esophageal cancer have shown promising organ preservation and survival signals, but direct comparisons versus surgery after neoadjuvant immunochemotherapy remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Volunteered to participate, cooperated with follow-up visits. 2. Aged 18 - 75 years (inclusive), male or female. 3. Histologically confirmed, resectable locally advanced ESCC, defined as cT1N1-3M0 or cT2-4aN0-3M0 according to the AJCC 8th edition, with cCR or PR achieved after 2-3 cycles of induction chemoimmunotherapy consisting of a permitted PD-1 inhibitor combined with a taxane and a platinum agent. 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. Life expectancy ≥ 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 ≥ 9 g/dL; 4. Serum albumin ≥ 2.8 g/dL; 5. Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or ALP ≤ 2.5 × ULN; 6. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min; 7. 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); 8. Comprehensive baseline staging evaluation prior to induction chemoimmunotherapy, including esophagogastroduodenoscopy with biopsy and/or EUS, contrast-enhanced CT of the neck, chest, and upper abdomen, MRI in patients without contraindications, and an upper gastrointestinal contrast study. PET/CT may be performed when clinically indicated and feasible. 9. Patients of childbearing potential must use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment period and within 6 months after the end of the study treatment; serum Human Chorionic Gonadotropin (HCG) or urine HCG test must be negative within 72 hours before study enrollment; and must not be breastfeeding. Exclusion Criteria: 1. Prior 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 before formal enrollment; 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. 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. Use of systemic corticosteroids at a dose \>10 mg/day prednisone equivalent or other systemic immunosuppressive therapy within 2 weeks before formal enrollment, except for inhaled or topical corticosteroids, physiologic hormone-replacement therapy, and short-term corticosteroids used for prophylaxis or treatment of allergic reactions, nausea, or vomiting; 4. Receipt of a live vaccine or antitumor vaccine within 4 weeks before formal enrollment; 8. 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; 9. Diagnosis of immunodeficiency, including positive HIV test, other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation; 10. 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; 11. Severe infections (CTCAE \> grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before formal enrollment; 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; 12. History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests; 13. Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment; 14. Active hepatitis B infection (HBV DNA \>2000 IU/mL) or active hepatitis C infection with detectable HCV RNA; 15. Presence of abnormal sodium, potassium, and calcium laboratory test values greater than grade 1 within 2 weeks prior to enrollment that do not improve with treatment; 16. Known hypersensitivity or contraindication to camrelizumab, nab-paclitaxel, carboplatin, or any component of the protocol-defined study treatments; 17. Previously diagnosed with any other malignancy within 5 years before the first use of the investigational drug, except for malignancies with low risk of metastasis and death (5-year survival rate\>90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ. 18. As judged by the investigator, the subject has other factors that may lead to forced termination of the study midway.
Where it's running
-
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Principal investigator: Wencheng Zhang, M.D. — Tianjin Cancer Hospital Airport Hospital
- Study coordinator: Wencheng Zhang, M.D.
- Email: zhangwencheng@tjmuch.com
- Phone: 02223340123
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
PF-08098488 in adults with advanced solid tumors
This study tests PF-08098488 in adults whose cancer has progressed or returned after prior treatment.
-
Modular Robot-Assisted Esophagectomy vs. Conventional Minimally Invasive Esophagectomy for Esophageal Cancer
This trial tests whether modular robotic-assisted esophagectomy using the Carina platform works better than conventional 3D thoracoscopic esophagectomy for people with resectable esophageal cancer.
-
MGC030 in adults with advanced solid tumors
This trial tests MGC030 in adults with advanced urothelial, gastric/GEJ, esophageal, colorectal, gastric, pancreatic, or GEJ cancers to see if it is safe and whether it can shrink tumors or stop growth.
-
Adding 2141-V11 to standard therapy for advanced esophageal, gastric, or gastroesophageal junction cancer
This study tests whether adding the drug 2141-V11 to standard anti-PD-1 therapy (with or without 5-FU) is safe for adults with advanced or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma.
-
TS-104: a first-in-human, dose-escalation study for advanced solid tumors
This study tests TS-104, a peptide-drug conjugate, as a single therapy in adults with advanced solid tumors like NSCLC, HNSCC, esophageal, gastric, ovarian, or endometrial cancer to see if it is safe and tolerable and whether it shows any benefit.
-
First-in-human STRO-006 in adults with certain recurrent or metastatic solid tumors
This study tests STRO-006 alone and with pembrolizumab in adults with certain head and neck, lung, esophageal, gastric, colorectal cancers to see if it is safe and shows early anticancer activity.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.