Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University
• Collaborator: Hangzhou DIAN Medical Diagnostic Center Co., Ltd., China
• Treatments: Poly(ADP-ribose) Polymerase Inhibitors

Criteria

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.