A Trial of Combination and Timing of Immunotherapy With Radiotherapy in Patients With Advanced Esophageal Squamous Cell Carcinoma.

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is a single-arm, prospective, phase II trial for patients with metastatic esophageal squamous cell carcinoma (ESCC) who received immunotherapy plus chemotherapy as the first-line treatment. The aim of the study is to determine if intervening with combined local therapy and immunotherapy and chemotherapy in patients with ESCC led to significant improvements in survival and disease control compared with historical data.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 18-80, had an Eastern Cooperative Oncology Group performance status score of 0-1;

• Patients had unresectable or recurrent esophageal squamous cell carcinoma that precluded esophagectomy or definitive chemoradiation, or distant metastatic disease;

• Patients had received no previous systemic therapy (patients who had progressed ≥6 months after \[neo\]adjuvant therapy or definitive chemoradiation were eligible);

• Patients accepted at least one cycle of anti-PD-1 immunotherapy combined chemotherapy as 1st line treatment.

• All lesions of current diagnosis did not receive local treatment such as radiotherapy, surgery, radiofrequency ablation before enrollment.

• The measurable lesion was determined by the investigator based on the RECIST 1.1 assessment. A lesion located in a previous radiotherapy area can be considered a target lesion if it is confirmed to progress and is considered to be measurable according to RECIST 1.1.

• Estimated survival time \>12 weeks.

• The function of vital organs meets the following requirements:

• Neutrophil absolute count (ANC) ≥ 1.5 × 10\^9 / L platelets ≥ 100 × 10\^9 / L; Hemoglobin ≥ 9g / dL; serum albumin ≥ 2.8g / dL; Total bilirubin ≤ 1.5 × ULN, ALT, AST and / or AKP ≤ 2.5 × ULN; if there is liver metastasis, ALT and / or AST ≤ 5 × ULN; if there is liver metastasis or bone metastasis AKP ≤ 5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance \> 60 mL / min; For patients with pulmonary lesions or previous lung irradiation who are known or suspected to have impaired lung function, the forced expiratory volume (FEV1) for 1 second of lung function must be above 1L.

• Female subjects of childbearing age must have a negative urine or serum pregnancy test within 72 hours prior to randomization. Subjects agreed to adequate contraception during the trial.

⁃ The patient is voluntarily enrolled and obtained the informed consent form signed by the patient or his legal representative.

Locations
Other Locations
China
Fudan University Shanghai cancer center
RECRUITING
Shanghai
Contact Information
Primary
Qi Liu, M.D.
18017317882@163.com
86-18017317882
Backup
Kuaile Zhao, M.D.
Time Frame
Start Date: 2023-02-28
Estimated Completion Date: 2026-08
Participants
Target number of participants: 100
Treatments
Experimental: Experimental group
Patients will be treated with anti-PD-1 Immune Checkpoint Inhibitors combined with chemotherapy used as 1st line treatment for metastatic ESCC.Radiotherapy will be conducted after four cycles of IO plus chemotherapy or started simultaneously.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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