MRD-Guided Consolidation Therapy Following Definitive Radiotherapy in Esophageal Cancer
NCT Number: NCT06498752
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophageal Cancer
Interventions: DRUG: PD-1 monoclonal antibody consolidation therapy
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators: Peking University Cancer Hospital & Institute|Hebei Medical University Fourth Hospital|Tianjin Medical University Cancer Institute and Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-16
Completion Date: 2025-06
Locations: Cancer hospital, CAMS, Beijing, Beijing, 100021, China

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.

Primary Outcome Measures: 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 Outcome Measures: 5-year overall survival, Overall survival was defined as the time from the end of radiotherapy to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported for all participants of the Intent-To-Treat (ITT) population. The Kaplan-Meier method was used to calculated the 5-year survival probability., 60 month|Cancer specific survival, From the end of radiotherapy to death specifically attributed to esophageal cancer., 60 month|Incidence of radiotherapy and immunotherapy related toxicity, Acute toxicity Rate, was defined as the frequency of toxicities related to the treatment, which arises during radiotherapy and within three month after the end of radiotherapy, according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 5.0 (CTC AE5.0). Late toxicity rate, was defined as the frequency of toxicities related to the treatment, which arises three month after the end of radiotherapy, according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 5.0 (CTC AE5.0)., Through study completion, an average of 3 year|Quality of life score(QOL) for swallowing function, Evluated by the score of the participants through The EORTC Quality of Life Questionnaire - Oesophageal Cancer Module (EORTC QLQ-OES18). The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores represent a higher ("worse") level of symptoms., 36 month|General Quality of life score(QOL), Change From Baseline in the EORTC QLQ-C30 Subscale Scores in Participants. The score of the participants evaluated by The EORTC core quality of life questionnaire (QLQ-C30). The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning., 36 month
Other Outcome Measures: Circulating DNA as biomarkers for the predicting of efficacy, To explore the dynamic changes of circulating tumor DNA (the frequency of specific mutations by Next-generation sequencing Methodology) from baseline, before and after radiotherapy and their relationship with recurrence., 36 months