Clinical trial · Observational
Prediction of the Efficacy of ctDNA in Immunotherapy for Advanced Gastric Cancer
A Prospective Study of Blood Circulating Tumor DNA for the Prediction of Efficacy in Immunotherapy for Advanced Gastric Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Gastric cancer is one of the common malignant tumors in China, with relatively high incident rate and mortality among the population. Surgery is the conventional treatment option for early and intermediate-stage stage gastric cancer, but postoperative relapse is the major issue. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring. The present clinical trial aims to explore the possibility of clinical utility of serum ctDNA as a clinical index to predict the efficacy in immunotherapy for advanced gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- the proportions of patients with positive serum ctDNA that have postoperative relapse
- timeFrame
- through study completion, an average of 2 years
- description
- the proportions of patients with positive serum ctDNA (in any follow-up) that have postoperative relapse
Secondary outcomes (1)
- measure
- The proportion of ctDNA content decreased in patients with good therapeutic effect
- timeFrame
- through study completion, an average of 2 years
- description
- The proportion of patients with good therapeutic effect whose serum ctDNA content decreased (in any follow-up）
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female ≥ 18 years of age at first visit. 2. Patients must have histologically confirmed gastric cancer . 3. Patients were surgically assessed to be inoperable. 4. Patients received second-line or third-line chemotherapy and were treated with immunoassay point inhibitors. 5. Patients' early pathological information was complete, including tumor site and pathological type. 6. Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS analysis. 7. Patients must be able to follow the study visit schedule and willing to provide peripheral blood samples at the indicated time point. 8. Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study. Exclusion Criteria: 1. Patients who cannot provide peripheral blood samples prior to the surgical treatment will be excluded. 2. Patients with severe infection will be excluded. 3. Patients with other serious disease besides gastric cancer will be excluded. 4. Pregnant women will be excluded. 5. Patients who are alcoholic or drug abusers will be excluded. 6. Patients with a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data will be excluded.
References
Publications (0)
Data not yet available