Real-world Study for Patients With Advanced Hepatobiliary Tumors

NCT03892577 | Unknown FDA Drug

• 1 other identifier: JS-1391
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators design a large sample size study in the real-world to explore whether targeted therapy and immunotherapy can improve the survival, quality of life and drug safety of patients with advanced hepatobiliary tumors, and analyze the correlation between genetic variation and the effectiveness of therapy.

Conditions

Objective Response Rate; Progression-free Survival; Overall Survival; Disease Control Rate; Duration of Response; Five-year Survival Rate; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  Time from the date of initial treatment to death for any cause.

  two years

• Progression-free Survival (PFS)

  A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.

  six months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  one year

• Disease Control Rate (DCR)

  six months

• Incidence of Treatment-Emergent Adverse Event

  one year

• Quality of Life (QoL) after treatment

  one year

Study Arms (1)

Patients with advanced hepatobiliary tumors

2000 patients with advanced hepatobiliary tumors will be enrolled and the enroll patients should be treat with any type of the following three treatment program: 1. Monotherapy or combination therapy with the targeted drug related to genetic variation of the subject; 2. Treatment with pan-target anti-angiogenic drugs, such as sorafenib, regorafenib, lenvatinib, apatinib, etc; 3. Immunotherapy or immunotherapy combined with targeted therapy or (and) chemotherapy.

Drug: Precision oncology including targeted therapy and immunotherapy

Interventions

Precision oncology including targeted therapy and immunotherapy DRUG

Therapeutic regimens are based on the clinicopathological features, genomic alterations, advices from multidisciplinary tumor board and willings from patients.

Patients with advanced hepatobiliary tumors

Eligibility Criteria

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

Study Population

Patients With Advanced Hepatobilary Tumors.

You may qualify if:

• Subjects must meet all of the following criteria：
• ≥18 years old, gender is not limited, and life expectancy is at least 6 months.
• Diagnosed as primary liver cancer or biliary malignant tumor by histopathology or confirmed by imaging as HCC (by the American Association for the Study of Liver Diseases or standard for the diagnosis and treatment of primary liver cancer 2017 in China).
• The Barcelona staging classification: class B-C.
• Child-Pugh classification: class A-B.
• At least one measurable lesion (RECIST v1.1)
• Unable to perform radical surgery or patient refuse surgery.
• Subjects need palliative treatment, and have received or are undergoing any of the following three treatments:
• Monotherapy or combination therapy with targeted drug associated with genetic variation in the subject.
• Or, treat with pan-target anti-vascular drugs, such as sorafenib, regorafenib, lenvatinib, apatinib.
• Or, immunotherapy or immunotherapy combined with targeted therapy or (and) classical chemotherapy.
• Subjects volunteer to participate in the study and sign informed consent.

You may not qualify if:

• Patients with one or more of the following criteria should be excluded:
• Patients with early hepatobiliary tumor.
• The Barcelona staging classification: class A.
• Child-Pugh classification: class C.
• Radical surgical resection.
• CT or MRI shows unclear tumor boundary or no measurable lesions (RECIST v1.1).
• Drug abuse, or any medical, psychological, or social condition that may affect the study, patient compliance, or even compromise the safety of the patient.
• Conduct other experimental drug treatments other than this test within 4 weeks before the start of the study; or participate in another clinical study that has an impact on the results of this study.
• Mental or medical instability makes patients unable or unwilling to sign informed consent.
• Patients after comprehensive assessment are considered by the investigators to be unsuitable for participating in the study.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• OrigiMed: collaborator

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

High-Throughput Sequencing

MeSH Terms

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Haitao Zhao

  Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Xiaobo Yang

CONTACT

010-69156043; zhaoht@pumch.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: March 27, 2019
• Study Start: July 1, 2017
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2025
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

CN (1)