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

Last updated: November 22, 2023
Sponsor: Hua Li
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Cancer

Abdominal Cancer

Digestive System Neoplasms

Treatment

Cisplatin injection

Gemcitabine Injection

Camrelizumab

Clinical Study ID

NCT05738057
[2023]02-116-01
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 EvaluationCriteria 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, hemoglobinconcentrations 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

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 curednon-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
  3. Active tuberculosis infection. Patients with active tuberculosis infection within 1year prior to enrollment; had a history of active tuberculosis infection more than 1year before enrollment, did not receive formal anti-tuberculosis treatment ortuberculosis 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 onlyhormone replacement therapy for hypothyroidism and skin diseases that do not requiresystemic therapy may be enrolled;
  7. Suffering from high blood pressure, and can not be well controlled by antihypertensivedrugs (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 ableeding 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 thetest by the investigator. Serious illnesses (including mental illness), severelaboratory tests, or other family or social factors that require combined treatment.

Study Design

Total Participants: 22
Treatment Group(s): 5
Primary Treatment: Cisplatin injection
Phase: 2
Study Start date:
June 30, 2023
Estimated Completion Date:
March 01, 2026

Connect with a study center

  • The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong
    China

    Active - Recruiting

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