Esophageal Squamous Cell Carcinoma, Unresectable Locally Advanced Esophageal Cancer
Conditions
Keywords
Immunotherapy, Induction immunochemotherapy, Concurrent Immuno-Chemoradiotherapy, Unresectable locally advanced esophageal cancer, Esophageal Squamous Cell Carcinoma
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 patients diagnosed with locally advanced, unresectable esophageal cancer.
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 tumor regression and reduced tumor residual achieved through immunochemotherapy offer an opportunity to enhance the effectiveness of subsequent radiotherapy. This phase I/II clinical study aims to investigate the efficacy and safety of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 for patients with unresectable locally advanced esophageal cancer. The study's co-primary endpoints are progression-free survival (PFS) and treatment completion rate.
Interventions
DRUGPD-1inhibitor
PD-1 inhibitor, Q3W, until disease progression or unacceptable toxicity or treatment reaches 1 year
Induction phase: nab-paclitaxel + cisplatin, Q3W × 2 cycles; Concurrent ICRT phase: nab-paclitaxel + cisplatin, QW × 5 cycles
RADIATIONRadiotherapy
Primary tumor and metastatic lymph nodes, DT:45-50Gy/25fx, starting within 4 weeks following the completion of the last induction immunochemotherapy cycle
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 75 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 3. Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification. 4. Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery. 5. No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy. 6. Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function. 7. Willingness to use contraception with an adequate method throughout the study. 8. Documented informed consent.
Exclusion criteria
1. History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components. 2. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators. 3. Weight loss exceeding 20% within the 90 days prior to the first day of drug administration. 4. Presence of long-standing unhealed wounds or fractures or undergoing major surgical resections within 60 days preceding the first day of drug administration. 5. 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 6. Occurrence of serious arterial/venous thrombotic events within 6 months prior to the first day of drug administration. 7. History of psychotropic substance abuse or inability to quit, or patients with psychotic disorders. 8. Allergy to study drugs. 9. Patients deemed unsuitable for participation due to severe comorbidities or other reasons determined by the investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Assessed up to 60 months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first |
| Treatment completion rate | 1 year | The Treatment Completion Rate is defined as the percentage of patients who successfully completed concurrent immuno-chemoradiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 1 year | Objective response rate (ORR), defined as the proportion of patients with a complete response or partial response after Immuno-Chemoradiotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) |
| Overall survival | Assessed up to 60 months | From date of randomization until the date of death from any cause |
| Incidence of Adverse events (AE) or severe adverse events (SAE) | 1 year | Adverse events (AE) or severe adverse events (SAE) occurring within 3 months post-radiotherapy, and the incidence of treatment discontinuation due to AE/SAE |
Countries
China
Contacts
Primary ContactWen Yu, M.D
Outcome results
None listed