Clinical trial · Interventional
Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics
A Real-world Study to Explore and Evaluate Individualized Targeted Agents for Patients of Digestive Cancers Based on Molecular Characteristics After Standard Therapy Failure in China
- 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)
This a prospective real-world navigation study using tumor DNA sequencing technology to sequence genes of previously treated and refractory gastrointestinal tumors, which are generally considered to be highly heterogeneous and complex, to screen potential molecular targeted drugs for individualized treatment. This study may provide feasibility and response information, which will be the basis for designing better randomized trials, which may change the pattern of cancer treatment. If the hypothesis is finally proved, it will help doctors and molecular biologists to choose the best drug (or combination of drugs) based on the individual oncogenomics of each patient.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Digestive Cancer | — | UNRESOLVED | — |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FGFR Inhibitor, IDH1 Inhibitor, HER2 Inhibitor, PARP Inhibitor, BRAF Inhibitor, MEK Inhibitor, ICIs, EGFR-TKIs, NTRK-TKI, and et. al. | Drug | — | UNRESOLVED |
| Other Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Matched Targeted Agent
- description
- Matched Targeted Agent
- interventionNames
- Drug: FGFR Inhibitor, IDH1 Inhibitor, HER2 Inhibitor, PARP Inhibitor, BRAF Inhibitor, MEK Inhibitor, ICIs, EGFR-TKIs, NTRK-TKI, and et. al.
- type
- ACTIVE_COMPARATOR
- label
- Unmatched Therapy
- description
- Unmatched Therapy
- interventionNames
- Drug: Other Therapy
Primary outcomes (1)
- measure
- Objective response rate (ORR) of patients receiving targeted agent
- timeFrame
- up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed recurrent or metastatic malignant tumors of digestive tract, including but not limited to: 1. Biliary tract cancer (including gallbladder cancer and cholangiocarcinoma) 2. Gastric cancer 3. Esophageal squamous cell carcinoma 4. Colorectal cancer 5. Gastrointestinal stromal tumor 6. Pancreatic cancer 7. Primary unknown metastatic carcinoma of digestive system * failure of conventional treatment; * have at least one measurable lesion according to RESIST1.1; * the target lesion is not suitable for local treatment; * the expected survival time was more than 3 months; * age ≥ 18 years old; * the main organs function well; * be able to swallow and retain oral medication if necessary; * patients must have enough tissue samples for gene mutation detection; * informed consent signed. Exclusion Criteria: * main lesions were suitable for local treatment; * serious or uncontrolled medical diseases that researchers consider to be confusing in the treatment response analysis (i.e. uncontrolled diabetes, chronic kidney disease, chronic lung disease or uncontrolled active infection, mental illness / social status that limits compliance with research requirements); * pregnant or lactating patients or any fertile patients taking no appropriate pregnancy prevention.
References
Publications (0)
Data not yet available