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

NCT04584008 | Active Not Recruiting DMC

• 1 other identifier: NGS01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biliary Tract Neoplasms; Gastric Cancer; Esophageal Squamous Cell Carcinoma; Colorectal Cancer; Gastrointestinal Stromal Tumors; Pancreatic Cancer; Neuroendocrine Tumors; Unknown Primary Cancer; Digestive Cancer

Keywords

Umbrella Study; Next Generation Sequence

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) of patients receiving targeted agent

  Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment

  up to 2 years

Secondary Outcomes (5)

• Proportion of patients with intervening genomic variation

  up to 2 years

• Progression Free Survival (PFS) of patients receiving targeted agent

  up to 2 years

• Overall Survival (OS) of patients receiving targeted agent

  up to 2 years

• Number of participants with treatment-related adverse events

  up to 2 years

• Differences of OS between 2 groups

  up to 2 years

Study Arms (2)

Matched Targeted Agent

EXPERIMENTAL

Matched Targeted Agent

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

Unmatched Therapy

ACTIVE COMPARATOR

Unmatched Therapy

Drug: Other Therapy

Interventions

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

According to the treatment dose approved by NMPA/FDA, evaluation will be conducted every 2 cycles until tumor progression or adverse events cannot be tolerated.

Also known as: Targeted Agent

Matched Targeted Agent

Other Therapy DRUG

Patients will receive other treatments, including cytotoxic drugs, antiangiogenic drugs, best supportive care, clinical trials of unmatched new drugs, etc..

Also known as: Other Drugs

Unmatched Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed recurrent or metastatic malignant tumors of digestive tract, including but not limited to:
• Biliary tract cancer (including gallbladder cancer and cholangiocarcinoma)
• Gastric cancer
• Esophageal squamous cell carcinoma
• Colorectal cancer
• Gastrointestinal stromal tumor
• Pancreatic cancer
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Hangzhou DIAN Medical Diagnostic Center Co., Ltd., China: collaborator
• 3D Medicines: collaborator

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms; Stomach Neoplasms; Esophageal Squamous Cell Carcinoma; Colorectal Neoplasms; Gastrointestinal Stromal Tumors; Pancreatic Neoplasms; Neuroendocrine Tumors; Neoplasms, Unknown Primary; Gastrointestinal Neoplasms

Interventions

Poly(ADP-ribose) Polymerase Inhibitors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Esophageal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Lin Shen, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 12, 2020
• Study Start: September 23, 2020
• Primary Completion: November 1, 2024
• Study Completion: March 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)