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Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics (VISIONARY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04584008
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Collaborator:
Hangzhou DIAN Medical Diagnostic Center Co., Ltd., China
Information provided by (Responsible Party):
Shen Lin, Peking University

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Neoplasms Gastric Cancer Esophageal Squamous Cell Carcinoma Colorectal Cancer Gastrointestinal Stromal Tumors Pancreatic Cancer Neuroendocrine Tumors Unknown Primary Cancer Digestive Cancer Drug: FGFR Inhibitor, IDH1 Inhibitor, HER2 Inhibitor, PARP Inhibitor, BRAF Inhibitor, MEK Inhibitor, ICIs, EGFR-TKIs, NTRK-TKI, and et. al. Drug: Other Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022


Arm Intervention/treatment
Experimental: Matched Targeted Agent
Matched Targeted Agent
Drug: FGFR Inhibitor, IDH1 Inhibitor, HER2 Inhibitor, PARP Inhibitor, BRAF Inhibitor, MEK Inhibitor, ICIs, EGFR-TKIs, NTRK-TKI, and et. al.
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.
Other Name: Targeted Agent

Active Comparator: Unmatched Therapy
Unmatched Therapy
Drug: Other Therapy
Patients will receive other treatments, including cytotoxic drugs, antiangiogenic drugs, best supportive care, clinical trials of unmatched new drugs, etc..
Other Name: Other Drugs




Primary Outcome Measures :
  1. Objective response rate (ORR) of patients receiving targeted agent [ Time Frame: up to 2 years ]
    Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment


Secondary Outcome Measures :
  1. Proportion of patients with intervening genomic variation [ Time Frame: up to 2 years ]
    Proportion of patients with intervening genomic variation

  2. Progression Free Survival (PFS) of patients receiving targeted agent [ Time Frame: up to 2 years ]
    Progression Free Survival (PFS) per RECIST 1.1 criteria according to investigators assessment

  3. Overall Survival (OS) of patients receiving targeted agent [ Time Frame: up to 2 years ]
    Overall Survival (OS) per RECIST 1.1 criteria according to investigators assessment

  4. Number of participants with treatment-related adverse events [ Time Frame: up to 2 years ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  5. Differences of OS between 2 groups [ Time Frame: up to 2 years ]
    Differences of OS between 2 groups per RECIST 1.1 criteria according to investigators assessment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584008


Contacts
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Contact: Lin Shen, MD 86-10-88196561 linshenpku@163.com

Locations
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China, Beijing
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Shen Lin, MD    010-88196561    Linshenpku@163.com   
Principal Investigator: Shen Lin, professor         
Sponsors and Collaborators
Peking University
Hangzhou DIAN Medical Diagnostic Center Co., Ltd., China
Investigators
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Principal Investigator: Lin Shen, MD Beijing Cancer Hospital
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Responsible Party: Shen Lin, Professor, Peking University
ClinicalTrials.gov Identifier: NCT04584008    
Other Study ID Numbers: NGS01
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shen Lin, Peking University:
Umbrella Study
Next Generation Sequence
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Esophageal Squamous Cell Carcinoma
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Biliary Tract Neoplasms
Neoplasms, Unknown Primary
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Esophageal Neoplasms
Head and Neck Neoplasms
Esophageal Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Biliary Tract Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors