Status:
RECRUITING
Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Esophageal Squamous Cell Carcinoma
Unresectable Locally Advanced Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
SCR-ESCC-02 is a multicenter, phase I/II clinical study to investigate the safety and efficacy of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 therapy in patien...
Detailed Description
Immunotherapy has shown promising results in advanced esophageal cancer, but its optimal integration into the management of unresectable locally advanced disease remains uncertain. The significant tum...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.
- Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery.
- No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
- Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function.
- Willingness to use contraception with an adequate method throughout the study.
- Documented informed consent.
Exclusion
- History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components.
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators.
- Weight loss exceeding 20% within the 90 days prior to the first day of drug administration.
- Presence of long-standing unhealed wounds or fractures or undergoing major surgical resections within 60 days preceding the first day of drug administration.
- Presence of any severe or uncontrolled coexisting diseases, including but not limited to:
- Uncontrolled hypertension
- History of interstitial lung disease or non-infectious pneumonia
- Active hepatitis B or C, syphilis, or other active and uncontrolled infections
- Cardiac insufficiency (NYHA≥2)
- Renal dysfunction requiring dialysis
- Active autoimmune disease
- History of acquired or congenital immunodeficiency diseases
- Occurrence of serious arterial/venous thrombotic events within 6 months prior to the first day of drug administration.
- History of psychotropic substance abuse or inability to quit, or patients with psychotic disorders.
- Allergy to study drugs.
- Patients deemed unsuitable for participation due to severe comorbidities or other reasons determined by the investigators.
Key Trial Info
Start Date :
January 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06173986
Start Date
January 10 2023
End Date
December 30 2027
Last Update
December 18 2023
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, China