Actively Recruiting
Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Patients With ESCC.
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-02-27
60
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is conducted in patients with unresectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 60 patients with unresectable locally advanced esophageal cancer in Tianjin cancer hospital. After 2 cycles of induction immunochemotherapy, 60 patients with ESCC will be divided into 2 groups (CR+PR group and SD+PD group) according to the efficacy of induction therapy. Patients in the CR+PR group will be treated with the same immunochemotherapy regimen plus concurrent radiotherapy (50.4Gy/1.8Gy/28f) . And immunotherapy will maintain for a maximum of 1 year. Patients in the SD+PD group will be treated with concurrent chemoradiotherapy (Radiotherapy: PTV/PGTV:50.4Gy/59.92Gy/28f and another chemotherapy regimen). Immunotherapy will not used during chemoradiotherapy because of immunotherapy resistance. The trial can effectively stratify patients by induction immunochemotherapy, and a more appropriate treatment regimen for patients has the potential to further improve PFS and prolong OS in all patients.
CONDITIONS
Official Title
Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Patients With ESCC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteered to participate and cooperate with follow-up visits
- Aged 18 to 75 years, any gender
- Histologically confirmed locally advanced unresectable esophageal squamous cell carcinoma (cT1N2-3M0, cT2-4bN0-3M0, or cT1-4bN0-3M1 with supraclavicular lymph node metastasis)
- Clinically staged as II-IVb and deemed inoperable or refusing surgery
- ECOG performance status of 0 or 1
- Presence of measurable or non-measurable lesions per RECIST 1.1
- No previous systemic anti-tumor therapy
- Able to provide fresh or archived tumor tissue samples within 6 months for biomarker analysis
- Expected survival of at least 3 months
- Adequate blood counts (ANC ≥1500/µl, platelets ≥100,000/µl, hemoglobin ≥9.0 g/dl)
- Adequate kidney function (creatinine ≤1.5× ULN or creatinine clearance ≥60 mL/min)
- Adequate liver function (bilirubin ≤1.5× ULN, ALT/AST/AKP ≤2.5× ULN, albumin ≥2.8 g/dl)
- Adequate coagulation (INR and APTT ≤1.5× ULN unless on anticoagulants within therapeutic range)
- Negative pregnancy test for women of childbearing potential within 3 days before treatment
- Provided informed consent
You will not qualify if you...
- Prior surgery for esophageal cancer
- Presence of esophageal fistula due to tumor infiltration
- High risk of gastrointestinal bleeding, esophageal fistula, or perforation
- Poor nutritional status with weight loss ≥10% in past 2 months without improvement
- Major surgery or severe trauma within 4 weeks before study treatment
- Uncontrollable pleural, pericardial effusion, or ascites needing repeated drainage
- Prior or current treatments including anti-PD-1/PD-L1 therapy, chemotherapy, radiotherapy, targeted therapy within 4 weeks before treatment
- Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressants within 2 weeks before treatment (exceptions apply)
- Prior anti-tumor vaccine or live vaccine within 4 weeks before treatment
- Active autoimmune diseases or history thereof, with some exceptions
- Immunodeficiency conditions including HIV or organ transplantation
- Uncontrolled heart conditions or recent myocardial infarction
- Severe infections within 4 weeks before treatment
- History of interstitial lung disease or severe pulmonary insufficiency
- Active tuberculosis infection or history within 1 year without treatment
- Active hepatitis B or C infection
- Significant abnormal sodium, potassium, or calcium lab values within 2 weeks before randomization
- Known allergy to study drugs or their components
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
W
Wencheng zhang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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