Clinical trial · Observational
Real-world Study for Patients With Advanced Hepatobiliary Tumors
Real-world Study for Targeted Therapy and Immunotherapy in Patients With Advanced Hepatobiliary Tumors: a Multi-centers, Open-assess Observational Study.
NCT03892577CI-TRIAL-00065157unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disease Control Rate | — | UNRESOLVED | — |
| Duration of Response | — | UNRESOLVED | — |
| Five-year Survival Rate | — | UNRESOLVED | — |
| Objective Response Rate | — | UNRESOLVED | — |
| Overall Survival | — | UNRESOLVED | — |
| Progression-free Survival | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Precision oncology including targeted therapy and immunotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with advanced hepatobiliary tumors
- description
- 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.
- interventionNames
- Drug: Precision oncology including targeted therapy and immunotherapy
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- two years
- description
- Time from the date of initial treatment to death for any cause.
- measure
- Progression-free Survival (PFS)
- timeFrame
- six months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Subjects must meet all of the following criteria： 1. ≥18 years old, gender is not limited, and life expectancy is at least 6 months. 2. 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). 3. The Barcelona staging classification: class B-C. 4. Child-Pugh classification: class A-B. 5. At least one measurable lesion (RECIST v1.1) 6. Unable to perform radical surgery or patient refuse surgery. 7. 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. 8. Subjects volunteer to participate in the study and sign informed consent. Exclusion Criteria: Patients with one or more of the following criteria should be excluded: 1. Patients with early hepatobiliary tumor. 2. The Barcelona staging classification: class A. 3. Child-Pugh classification: class C. 4. Radical surgical resection. 5. CT or MRI shows unclear tumor boundary or no measurable lesions (RECIST v1.1). 6. Drug abuse, or any medical, psychological, or social condition that may affect the study, patient compliance, or even compromise the safety of the patient. 7. 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. 8. Mental or medical instability makes patients unable or unwilling to sign informed consent. 9. Patients after comprehensive assessment are considered by the investigators to be unsuitable for participating in the study.
References
Publications (29)
- BACKGROUNDChen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. PMID 26808342
- BACKGROUNDMoriguchi M, Umemura A, Itoh Y. Current status and future prospects of chemotherapy for advanced hepatocellular carcinoma. Clin J Gastroenterol. 2016 Aug;9(4):184-90. doi: 10.1007/s12328-016-0670-7. Epub 2016 Jul 11. PMID 27401471
- BACKGROUNDLlovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857. PMID 18650514
- BACKGROUNDCheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16. PMID 19095497
- BACKGROUNDSharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. doi: 10.1200/JCO.2010.29.3605. Epub 2010 Sep 20. PMID 20855823
- BACKGROUNDRodriguez R, Miller KM. Unravelling the genomic targets of small molecules using high-throughput sequencing. Nat Rev Genet. 2014 Dec;15(12):783-96. doi: 10.1038/nrg3796. Epub 2014 Oct 14. PMID 25311424