Phase 2 Study of Anti-PD-1 Immunotherapy Combined With Stereotactic Body Radiation Therapy for Patients With Oligometastatic Esophageal Squamous Cell Carcinoma

Sun Yat-sen University1 site in 1 country40 target enrollmentDecember 10, 2022

ConditionsEsophageal Squamous Cell Carcinoma Oligometastatic Disease

InterventionsPD-1 combined with SBRT

DrugsPD-1 combined with SBRT

Overview

Phase: Phase 2
Intervention: PD-1 combined with SBRT
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 40
Locations: 1
Primary Endpoint: 1-year progression-free survival
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this phase II clinical trial is to explore the efficacy and safety of anti-PD1 combined with stereotactic body radiation therapy (SBRT) for patients with oligometastatic esophageal squamous cell carcinoma. Participants will receive anti-PD1 and SBRT to the metastatic lesions which are amenable to the delivery of SBRT after 4~6 cycles of systemic chemotherapy and anti-PD-1.

Registry

clinicaltrials.gov

Start Date

December 10, 2022

End Date

January 1, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Mian XI

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Eastern Cooperative Oncology Group performance status ≤ 2;
•Histologically confirmed squamous cell carcinoma of the esophagus;
•Diagnosed with stage IVB disease (according to UICC TNM version 8) with less than five metastatic lesions within three organs;
•Received 4 to 6 cycles of standard chemotherapy (fluoropyrimidine or taxane-based platinum doublet chemotherapy) and anti-PD1 treatment, and no progression disease was confirmed;
•At least one metastatic lesions amenable to the delivery of SBRT;
•Estimated life expectancy \>4 months;
•The function of important organs meet the following requirements: a. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate \>60 mL/min;
•Ability to understand the study and sign informed consent.

Exclusion Criteria

•Progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy and anti-PD1 treatment;
•Patients with intracranial metastasis disease at diagnosis;
•History of thoracic irradiation;
•Known or suspected allergy or hypersensitivity to monoclonal antibodies and the chemotherapeutic drugs: Capecitabine, paclitaxel, or platinum;
•Patients have spinal bone metastases combined with spinal cord compression;
•A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
•Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver, or kidney dysfunction, or hematopoietic disease or cachexia;
•Inability to provide informed consent due to psychological, familial, social, and other factors;
•Female patients who are pregnant or during lactation;
•Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation;

Arms & Interventions

PD-1 combined with SBRT for metastatic lesions

Participants will receive anti-PD1 and SBRT to the metastatic lesions which are amenable to the delivery of SBRT after 4\~6 cycles of systemic chemotherapy and anti-PD-1. SBRT for the metastatic lesions shall be conducted within two months after the completion of systemic therapy. The prescription of SBRT is determined by the investigator and the BED is required to over 50Gy.

Intervention: PD-1 combined with SBRT

Outcomes

Primary Outcomes

1-year progression-free survival

Time Frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 12 months

1-year progression-free survival

Secondary Outcomes

1-year overall survival(From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 12 months)
ORR(3 months after SBRT (plus or minus 14 days)])
Treatment-related adverse events(From the start of treatment to 2 year after the completion of treatment)