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RecruitingNCT05738057Updated Nov 29, 2023

Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and PD1 Antibody in Advanced and Unresectable Intrahepatic Cholangiocarcinoma

A Phase 2 interventional study of Camrelizumab and Gemcitabine Injection in Unresectable Intrahepatic Cholangiocarcinoma, sponsored by Hua Li. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Hua Li · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to learn about the combined therapy using drug-eluting bead-transarterial chemoembolization (D-TACE), gemcitabine (Gem) and cisplatin (Cis) chemotherapy, and PD-1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are:

  • Whether combined therapy using D-TACE, Gem/Cis, and PD-1 works well to convert unresectable ICC to resectable.
  • Whether combined therapy using D-TACE, Gem/Cis, and PD-1 is safe. Participants will receive D-TACE (CalliSpheres with Gem 30 mg), camrelizumab (200 mg) plus gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2), and 24 months follow-up.
02

Conditions studied

  • Unresectable Intrahepatic Cholangiocarcinoma

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03

In context

Cholangiocarcinoma

914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.

This study's planned enrollment of 22 is below the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Hua Li is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years old, male or female;
  2. Histopathologically confirmed intrahepatic cholangiocarcinoma;
  3. Tumor is unresectable assessed by the expert group (R0 resection CANNOT be achieved) and the life expectancy is more than 3 months;
  4. Presence of at least one measurable lesion assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1);
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Child-Pugh score ≤ 7;
  7. Adequate organ function (neutrophil count of ≥1.5×10\^9 cells/L, hemoglobin concentrations of ≥90 g/L, platelet cell count of ≥100×10\^9 cells/L, bilirubin ≤1.5×ULN, Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 5×ULN, serum creatinine ≤ 1.5 x ULN, Thyroid stimulating hormone (TSH) ≤ 1 x ULN;
  8. The patient must be required to sign an informed consent form;

Exclusion criteria

Exclusion Criteria:

  1. Patients who have received previous treatment with interventional therapy, radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy (PD-1, PD-L1, CLTA-4 antibody, etc), or surgery within the last 2 months;
  2. Patients with other malignant tumors within the last 5 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
  3. Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; had a history of active tuberculosis infection more than 1 year before enrollment, did not receive formal anti-tuberculosis treatment or tuberculosis is still active;
  4. Active infection requiring systemic therapy;
  5. Human immunodeficiency virus (HIV) positive;
  6. Have an active, known, or suspected autoimmune disease. Subjects who require only hormone replacement therapy for hypothyroidism and skin diseases that do not require systemic therapy may be enrolled;
  7. Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
  8. Abnormal blood coagulation (INR >1.5, or PT>ULN+4s, or APTT >1.5 x ULN), with a bleeding tendency or receiving thrombolytic or anticoagulant therapy;
  9. Pregnant or lactating women;
  10. Participated in other trials within the last 4 weeks;
  11. Has a history of allergy to platinum;
  12. Other factors that may influence the safety of the subject or the compliance of the test by the investigator. Serious illnesses (including mental illness), severe laboratory tests, or other family or social factors that require combined treatment.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and Camrelizumab

    D-TACE with cisplatin-eluting beads. More TACE can be done if clinically necessary. Camrelizumab (200 mg, Intravenous drips (ivd), D1/3W) plus Gem (1000 mg/m2, ivd, D1\&8/3W) and Cis (25 mg/m2, ivd, D1\&8/3W). Three weeks are one cycle of treatment. Chemotherapy lasted for no more than 12 cycles.

    Drug: Camrelizumab · Drug: Gemcitabine Injection · Drug: Cisplatin injection · Drug: Cisplatin-Eluting Beads · Procedure: D-TACE

Interventions

  • DrugCamrelizumab

    200mg on day1 of every 3 weeks, starting on day1 of cycle1

  • DrugGemcitabine Injection

    1000mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1

  • DrugCisplatin injection

    25mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1

  • DrugCisplatin-Eluting Beads

    used for D-TACE

  • ProcedureD-TACE

    TACE with Cisplatin-Eluting Beads (with Cis 30mg). More TACE can be done if clinically necessary.

06

What researchers measure

Primary outcomes

  1. Conversion rate

    Rate of unresectable ICC convert to resectable in combination therapy

    Time frame: 12 months

Secondary outcomes

  1. Incidence of adverse events

    Rate of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 12 months

  2. Objective Response Rate (ORR)

    ORR according to RECIST 1.1 using investigator assessment

    Time frame: 12 months

  3. Deepness of response (DpR)

    DpR according to RECIST 1.1 using investigator assessment

    Time frame: 12 months

  4. Disease control rate (DCR)

    DCR according to RECIST 1.1 using investigator assessment

    Time frame: 12 months

  5. Rate of R0 resection

    R0 resection is defined as no tumor remains at the cutting edge and no tumor cells remain at the cutting edge under the microscope

    Time frame: 12 months

  6. Overall Survival (OS)

    OS is defined as the time from date of combined theray start to the date of death from any cause or to the date of last follow-up if patients are alive.

    Time frame: 12 months

  7. Progression-free Survival (PFS)

    From the beginning date of combined therapy to the date of disease progression. PFS according to RECIST 1.1 using investigator assessment

    Time frame: 12 months

  8. Recurrence-free Survival (RFS)

    RFS is defined as the time between the date of surgery and the date of disease recurrence or death, whichever occurred first. RFS according to RECIST 1.1 using investigator assessment

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • The Third Affiliated Hospital of Sun Yat-Sen University
    Guangzhou, Guangdong, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05738057
Lead sponsor
Hua Li
Responsible party
Hua Li (Director, Hepatic Surgery Department of Third Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University) — Sponsor-investigator
First posted
Feb 21, 2023
Start date
Jun 30, 2023
Primary completion
Mar 1, 2025 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Nov 29, 2023

Study contacts

Hua Li, MD&PhD
Contact
lihua100@yeah.net
+8613060975202
Linsen Ye, MD&PhD
Contact
ye_linsen@163.com
+8618520788663
Yang Yang, MD&PhD
study chair · Third Affiliated Hospital, Sun Yat-Sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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