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

Plain-language summary

This study evaluates targeted drugs (FGFR, IDH1, HER2, PARP, BRAF and MEK inhibitors, immune checkpoint inhibitors, EGFR-TKIs and others) selected according to the tumor's molecular features in patients with digestive-tract cancers (such as biliary, gastric, esophageal, colorectal and pancreatic cancers) in China. It can enroll patients aged 18 and older whose disease has not responded to standard treatment, who have measurable disease and enough tissue for gene mutation testing. It is a study without an assigned phase and is currently not recruiting but still ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Active, not recruiting

Sponsor

Peking University

Intervention

FGFR Inhibitor, IDH1 Inhibitor, HER2 Inhibitor, PARP Inhibitor, BRAF Inhibitor, MEK Inhibitor, ICIs, EGFR-TKIs, NTRK-TKI, and et. al., Other Therapy

Start date

9/23/2020

Estimated completion

3/1/2025

Countries

China

Related genes

Locations

• Beijing, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.