Dynamic ctDNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
This is a single-center, prospective, exploratory study evaluating the use of dynamic circulating tumor DNA (ctDNA) monitoring in the postoperative adjuvant treatment setting for patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma.
After curative-intent surgery, patients remain at risk of disease recurrence. Postoperative treatment decisions are currently based on clinicopathological factors, which may not fully reflect minimal residual disease. ctDNA is a blood-based biomarker that can detect tumor-derived DNA fragments and may provide additional information on recurrence risk.
In this study, ctDNA will be assessed at predefined perioperative and postoperative time points using peripheral blood samples. The primary objective is to evaluate 1-year disease-free survival. Secondary objectives include survival outcomes, safety, and longitudinal changes in ctDNA status. The findings of this exploratory study may inform future research on ctDNA-guided postoperative management in gastric cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily participate in the study; fully understand the study and sign the written informed consent form (ICF); be willing and able to comply with all study procedures.
Male or female patients aged ≥18 years and ≤75 years at the time of signing the ICF.
Histologically confirmed, previously untreated gastric cancer or gastroesophageal junction (GEJ) cancer, with adenocarcinoma as the predominant histology. For GEJ cancer, only Siewert type III and Siewert type II tumors not requiring thoracotomy are eligible.
Clinically confirmed stage III or stage IVA disease without distant metastasis, as assessed by the treating physician prior to enrollment.
Disqualifiers
History of another active malignancy within the past 5 years or concurrent malignancy, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast.
Presence of distant metastasis (M1) from gastric cancer.
Prior or planned organ or bone marrow transplantation.
History of myocardial infarction within 6 months prior to enrollment, or poorly controlled arrhythmia, including QTc prolongation (QTc ≥450 ms in males or ≥470 ms in females, calculated using Fridericia's formula).
Trial design
Design model
Parallel
Treatments tested in this trial
HLX10
DrugHLX10 is a programmed death-1 (PD-1) monoclonal antibody administered as postoperative adjuvant treatment
SOX Chemotherapy
DrugSOX chemotherapy consists of S-1 in combination with oxaliplatin and is administered as part of postoperative adjuvant treatment
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: ctDNA-Positive（after surgery）Experimental treatment 2 interventions
Group B: ctDNA-Negative（after surgery）Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
1 year Disease-Free Survival rate
Disease-Free Survival rate at 1 year
Time frame
Up to 1 year after surgerySecondary outcomes
1
Disease Control Rate
the proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD), as assessed according to RECIST version 1.1.
Time frame
During perioperative treatment2
Major Pathological Response (MPR) Rate
the proportion of patients with ≤10% residual viable tumor cells in the resected tumor specimen, as assessed by pathological examination after surgery
Time frame
At the time of surgery3
3-year Disease-Free Survival Rate
the proportion of patients who remain alive without disease recurrence or metastasis within 3 years after surgery.
Time frame
Up to 3 years after surgery4
5-year Disease-Free Survival Rate
the proportion of patients who remain alive without disease recurrence or metastasis within 5 years after surgery.
Time frame
Up to 5 years after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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