MRD-Guided Consolidation Therapy Following Definitive Radiotherapy in Esophageal Cancer

NCT06498752 | Recruiting Phase 2

• 1 other identifier: BEIR 2
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

To further validate the performance of the high-sensitivity MRD assay in patients with squamous esophageal cancer who have completed radical radiotherapy; to validate whether MRD-negative patients can maintain a good prognosis under regular follow-up; and to validate whether MRD-positive patients can improve their survival with consolidation therapy with PD-1 monotherapy.

Conditions

Esophageal Cancer

Keywords

Esophageal squamous cell carcinoma; Immune checkpoint inhibitor; immunotherapy; chemotherapy; radiotherapy; Minimal residual disease, MRD

Outcome Measures

Primary Outcomes (1)

• Median progression-free survival (PFS)

  Median progression-free survival (PFS), was defined as the time from the end of radiotherapy to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first.

  36 month

Secondary Outcomes (5)

• 5-year overall survival

  60 month

• Cancer specific survival

  60 month

• Incidence of radiotherapy and immunotherapy related toxicity

  Through study completion, an average of 3 year

• Quality of life score(QOL) for swallowing function

  36 month

• General Quality of life score(QOL)

  36 month

Other Outcomes (1)

• Circulating DNA as biomarkers for the predicting of efficacy

  36 months

Study Arms (2)

MRD negative

NO INTERVENTION

Intervention name: regular review of MRD monitoring; Intervention description: thoracic and abdominal CT, Esophagography and MRD monitoring every 3 months for 2 years after completion of radiotherapy

MRD positive

EXPERIMENTAL

Intervention name: PD-1 monoclonal antibody consolidation therapy;

Drug: PD-1 monoclonal antibody consolidation therapy

Interventions

PD-1 monoclonal antibody consolidation therapy DRUG

PD-1 monoclonal antibody-based consolidation therapy for 1 year after completion of radiotherapy (or combination chemotherapy up to 4 cycles if less than 4 cycles of chemotherapy). Specific dosing: PD-1 monoclonal antibody, 200mg every 3 weeks.

MRD positive

Eligibility Criteria

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

You may qualify if:

• ≥18 years, any gender
• Histologically or cytologically confirmed squamous cell carcinoma of esophageal cancer. The initial clinical stage is I-VIa (2018 AJCC Cancer Staging Manual, 8th Edition) , primary unresectable oesophageal cancer
• ECOG performance status \<= 1.
• No significant abnormality in laboratory routine indicators such as blood routine and liver and kidney function
• Completed radical radiotherapy (dose 50-60Gy);
• Received a systemic regimen of platinum in combination with paclitaxel or a 5-FU-based two-drug regimen with or without PD-1 monotherapy in accordance with the CSCO guidelines, and S-1 monotherapy in elderly patients;
• Informed consent

You may not qualify if:

• Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ.
• Active infection currently exists, serious illness such as myocardial infarction in the 6 months prior to enrolment
• History of autoimmune diseases
• Participate in other clinical trials at present or within 4 weeks before enrollment;
• Received systemic therapy (chemotherapy alone or chemotherapy combined with immunotherapy) for more than 4 cycles.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Peking University Cancer Hospital & Institute: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (1)

Cancer hospital, CAMS

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 12, 2024
• Study Start: July 16, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

CN (1)