Dynamic ctDNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma

NCT07507916 | Not Yet Recruiting Phase 2

• 2 other identifiers: SOLIDS-07Shanghai Cancer Center
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ctDNA; Gastric Cancer; Gastroesophageal Junction (GEJ) Adenocarcinoma; Adjuvant Treatment

Outcome Measures

Primary Outcomes (1)

• 1 year Disease-Free Survival rate

  Disease-Free Survival rate at 1 year

  Up to 1 year after surgery

Secondary Outcomes (7)

• Disease Control Rate

  During perioperative treatment

• Major Pathological Response (MPR) Rate

  At the time of surgery

• 3-year Disease-Free Survival Rate

  Up to 3 years after surgery

• 5-year Disease-Free Survival Rate

  Up to 5 years after surgery

• Median Disease-Free Survival

  Up to 5 years after surgery

Study Arms (2)

ctDNA-Positive（after surgery）

EXPERIMENTAL

Patients with detectable circulating tumor DNA (ctDNA) after surgery will receive adjuvant treatment with HLX10 in combination with SOX chemotherapy

Drug: HLX10; Drug: SOX Chemotherapy

ctDNA-Negative（after surgery）

EXPERIMENTAL

Patients without detectable circulating tumor DNA (ctDNA) after surgery will receive adjuvant treatment with HLX10 monotherapy

Drug: HLX10

Interventions

HLX10 DRUG

HLX10 is a programmed death-1 (PD-1) monoclonal antibody administered as postoperative adjuvant treatment

ctDNA-Negative（after surgery）; ctDNA-Positive（after surgery）

SOX Chemotherapy DRUG

SOX chemotherapy consists of S-1 in combination with oxaliplatin and is administered as part of postoperative adjuvant treatment

ctDNA-Positive（after surgery）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• HER2-negative disease.
• Adequate cardiac function and deemed suitable for curative-intent surgical resection. Patients with ischemic heart disease, valvular disease, or other significant cardiac conditions should undergo preoperative evaluation by a cardiologist if clinically indicated.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to enrollment.
• Estimated life expectancy of at least 6 months.
• Negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core antibody (HBcAb). If HBsAg-positive or HBcAb-positive, hepatitis B virus DNA (HBV-DNA) must be \<1000 copies/mL, \<200 IU/mL, or below the upper limit of normal (ULN) of the study center.
• Negative hepatitis C virus (HCV) antibody.
• Adequate organ function, defined as follows (without transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factors within 14 days prior to randomization):
• Hematologic function
• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
• Platelet count ≥ 100 × 10⁹/L
• Hemoglobin ≥ 90 g/L Hepatic function

You may not qualify if:

• 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).
• New York Heart Association (NYHA) class III-IV heart failure, or left ventricular ejection fraction (LVEF) \<50% on echocardiography.
• Known human immunodeficiency virus (HIV) infection.
• Active pulmonary tuberculosis.
• Current or prior interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction that may interfere with the assessment or management of suspected drug-related pulmonary toxicity.
• Known active or suspected autoimmune disease, except for patients with stable disease not requiring systemic immunosuppressive therapy at enrollment.
• Receipt of a live vaccine within 28 days prior to enrollment (seasonal influenza vaccines with inactivated virus are allowed).
• Requirement for systemic corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressive therapy within 14 days prior to enrollment or during the study, except for:
• Topical or inhaled corticosteroids;
• Physiologic replacement therapy with prednisone ≤10 mg/day in the absence of active autoimmune disease.
• Active infection requiring systemic anti-infective therapy within 14 days prior to enrollment (prophylactic antibiotics, such as for urinary tract infection or chronic obstructive pulmonary disease, are allowed).
• Prior treatment with immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Jun Lu

CONTACT

18916871096; lujun@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fudan University Shanghai Cancer Center

Model Details: Dynamic circulating tumor DNA (ctDNA) assessments are performed at predefined perioperative and postoperative time points, and clinical outcomes are evaluated longitudinally during postoperative adjuvant treatment and follow-up.

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share