Helicobacter pylori Infection and Its Effects on Immunotherapy Outcomes in Advanced Gastric Cancer: A Multicenter, Prospective Clinical Research (HOPE-GC)

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500115665

Enrollment

Unknown

Registered

2025-12-30

Start date

2025-12-30

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Pylori negative group:No intervention

Pylori positive group:No intervention

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Older than 18 years; Gender unlimited; 2. Patients with confirmed advanced gastric cancer (patients with resectable and unresectable locally advanced and advanced metastatic gastric cancer) 3. Patients who met the indication of immunotherapy and had not received gastric cancer-related treatment before; 4.Able to tolerate H. pylori detection (including C13 / 14 breath test, stool antigen detection, H. pylori immunohistochemistry and serum antibody detection); 5.Patients who can tolerate endoscopic gastric mucosal biopsy or can provide the first confirmed gastric tissue section of gastric cancer; 6.Informed consent was obtained.

Exclusion criteria

Exclusion criteria: 1.Patients with other malignant tumors (except cured skin basal cell carcinoma or cervical carcinoma in situ) were excluded; 2.Those who have active autoimmune disease or history and may relapse; 3.Active infection (such as tuberculosis, HIV, hepatitis B or C); 4.Serious uncontrolled cardiovascular disease (such as unstable angina pectoris, myocardial infarction within 6 months, heart failure with New York Heart Association grade = III); 5. Severe neurological diseases (such as uncontrolled epilepsy, uncontrolled brain metastasis); 6. Patients with severe bleeding tendency or coagulation dysfunction; 7.Pregnant or lactating women; 8.Organ transplant recipients who have previously received organ transplants that may lead to immunosuppression and patients who need long-term glucocorticoids due to illness; 9. Those with mental or cognitive impairment who cannot understand the research procedures or provide informed consent; 10. Other circumstances that the researcher believes are not suitable for participation in this study.

Design outcomes

Primary

Measure	Time frame
Disease Controlled Rate, DCR;Objective Response Rate,ORR;	—

Countries

China

Contacts

Public ContactLiang Deng

The First Affiliated Hospital of Chongqing Medical University

dengliang@cqmu.edu.cn+86 189 8328 0109

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026