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Immune checkpoint inhibitors plus tyrosine kinase inhibitors in unresectable intrahepatic cholangiocarcinoma: a multicenter real world study

Immune checkpoint inhibitors plus tyrosine kinase inhibitors in unresectable intrahepatic cholangiocarcinoma: a multicenter real world study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046783
Enrollment
Unknown
Registered
2021-05-28
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic cholangiocellular carcinoma

Interventions

Case series:Immune checkpoint inhibitors plus tyrosine kinase inhibitors

Sponsors

Zhongda Hospital of Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged >=18 years, male or female; 2.Patients with intrahepatic cholangiocarcinoma confirmed by histological or cytological examination; 3.Inoperable patients,Postoperative recurrence and cannot be re-operated,Relapsed or residual after RFA/TACE treatment and unreoperable; 4.Measurable lesions conforming to RECIST 1.1, RECIST, and IRECIST standards; 5.Use ICIs plus tyrosine kinase inhibitor; 6.At least one follow-up imaging assessment.

Exclusion criteria

Exclusion criteria: 1.Patients with hepatocellular carcinoma, mixed cell carcinoma or fibrotic laminar cell carcinoma diagnosed pathologically; 2.Patients with previous or concurrent malignancies (except for skin basal cell carcinoma, prostate cancer in situ and cervical carcinoma in situ); 3.Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders; 4.Patients with any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; subjects who need bronchodilator for medical intervention cannot be included); but the following patients are allowed to be included: vitiligo, psoriasis, alopecia, control group without systemic treatment Patients with type I diabetes were treated with replacement therapy for hypothyroidism with normal thyroid function; 5.According to the researchers' judgment, there were other patients who were not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Secondary

MeasureTime frame
progress free survival;overall survival;rate of adverse reaction;

Countries

China

Contacts

Public ContactCheng Zhangjun

Zhongda Hospital of Southeast University

chengzhangjun@seu.edu.cn+86 13705151608

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026