A Study of IO Plus Radiotherapy in Patients With Advanced ESCC.

NCT05760391 | Recruiting

• 1 other identifier: ESO-Shanghai 19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• OS from start of 1st line treatment in metastatic ESCC

  Median OS and OS rate at 12 months and 24 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.

  2 years

Secondary Outcomes (2)

• PFS from start of 1st line treatment in metastatic ESCC

  18 months

• Disease control rate

  Evaluation at the end of radiotherapy and after every 2 months of systemic therapy.

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

IMRT or SABR for patients with ESCC.

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who are prior exposure to immune-mediated therapy.
• Patients participated in any investigational drug study within 4 weeks preceding the start of treatment.
• Patients with uncontrolled brain metastases, or vertebral body metastasis with spinal cord compression symptoms.
• Patients with uncontrolled pleural, pericardial or pelvic effusion that requires repeated drainage.
• Patients with history of immunodeficiency, or severe medical diseases that are not well controlled, which may have effect on the treatment of this study.
• Any other malignant tumor was diagnosed within 5 years prior to or after the diagnosis of ESCC, except for malignant tumors with a low risk of metastasis and death (5-year survival rate \>90%), such as well-treated basal cells or squamous cell skin cancer or cervical cancer in situ.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai cancer center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Qi Liu, M.D.

CONTACT

86-18017317882; 18017317882@163.com

Kuaile Zhao, M.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 8, 2023
• Study Start: February 28, 2023
• Primary Completion: February 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 25, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)