Actively Recruiting
DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR/PR After nCI
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-05-13
120
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
S
Shanxi Province Cancer Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 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
Official Title
DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR/PR After nCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteered to participate and cooperate with follow-up visits
- Aged 18 to 75 years, male or female
- Histologically confirmed locally advanced resectable esophageal squamous cell carcinoma, clinically staged as Stage II to IVa before treatment
- Achieved complete or partial clinical response after 2 cycles of platinum-based chemotherapy combined with anti-PD-1 or PD-L1 antibodies
- Presence of measurable or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer
- ECOG performance status score of 0 or 1
- Estimated survival time of at least 3 months
- Adequate major organ function including specified blood counts, liver and kidney function, and coagulation parameters
- Completed comprehensive baseline staging evaluation prior to induction chemo-immunotherapy
- Use of medically approved contraceptive methods during treatment and within 6 months after treatment for patients of childbearing potential
- Negative serum or urine Human Chorionic Gonadotropin (HCG) test within 72 hours before enrollment
- Not breastfeeding
You will not qualify if you...
- Previous surgery for esophageal cancer
- Presence of esophageal fistulae due to tumor infiltration
- Risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation
- Poor nutritional status with weight loss of 10% or more in the past 2 months without significant improvement
- Major surgery or severe trauma within 4 weeks before starting study treatment
- Uncontrollable pleural, pericardial effusion, or ascites requiring repeated drainage
- Previous or ongoing treatments including certain immunotherapies, chemotherapy, radiotherapy, targeted therapies, investigational agents, or systemic corticosteroids above specified doses
- Received anti-tumour or live vaccines within 4 weeks before the first study dose
- Active autoimmune disease or history of autoimmune disease, except specified conditions
- Diagnosed immunodeficiency or history of organ or bone marrow transplantation
- Uncontrolled cardiac conditions or significant arrhythmias
- Severe infections within 4 weeks before study treatment
- History of interstitial lung disease, non-infectious pneumonia, or severe pulmonary insufficiency
- Active or recent tuberculosis infection
- Active hepatitis B or C infection
- Abnormal electrolyte laboratory values not improved with treatment
- Known hypersensitivity to study drugs or components
- History of other malignancies except low-risk skin or cervical cancers
- Other factors judged by investigators that may cause study withdrawal
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
W
Wencheng Zhang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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