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A retrospective cohort study based on real-world data evaluating the efficacy and safety of PD-1/PD-L1 inhibitors combined with gemcitabine/cisplatin versus gemcitabine/cisplatin alone as first-line treatment for advanced intrahepatic cholangiocarcinoma

A retrospective cohort study based on real-world data evaluating the efficacy and safety of PD-1/PD-L1 inhibitors combined with gemcitabine/cisplatin versus gemcitabine/cisplatin alone as first-line treatment for advanced intrahepatic cholangiocarcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117218
Enrollment
Unknown
Registered
2026-01-21
Start date
2026-01-22
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

intrahepatic cholangicarcinoma

Interventions

Immunotherapy combined with chemotherapy group :N/A
Chemotherapy alone group :N/A

Sponsors

Ningbo Medical Centre Lihuili Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>= 18 years; 2. Clinically diagnosed or confirmed by pathology or cytology as intrahepatic cholangiocarcinoma (ICC); 3. Clinically staged as locally advanced or metastatic (IIIB-IV stage) disease that is not surgically resectable; 4. Initiated first-line systemic treatment at this center between January 1, 2016, and June 30, 2025; 5. First-line treatment regimen is clearly defined as: A. PD-1/PD-L1 inhibitor combined with gemcitabine + cisplatin (cisplatin may be replaced with oxaliplatin or nedaplatin);or B. Gemcitabine + cisplatin (as above); 6. Available baseline and at least one post-treatment imaging evaluation data.

Exclusion criteria

Exclusion criteria: 1. Previously received systemic anti-tumor therapy for advanced disease; 2. Concurrent with other active malignancies (except cured cutaneous basal cell carcinoma or cervical carcinoma in situ); 3. Severe deficiency in medical records, making it impossible to evaluate primary efficacy or safety; 4. Concurrent participation in other interventional clinical trials that may interfere with the evaluation of the endpoints of this study.

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
Adverse event;

Countries

China

Contacts

Public ContactCaide Lu

Ningbo Medical Centre Lihuili Hospital

lucaide@nbu.edu.cn+86 5745583580

Outcome results

None listed

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