Combined therapy for advanced intrahepatic cholangiocarcinoma

Combined Therapy Using D-TACE, Gemcitabine and Cisplatin Chemotherapy, and PD1 Antibody for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: a Single-center, Single-arm Trial

This study is testing a new combination treatment for patients with advanced bile duct cancer to see if it can make their tumors operable and improve their health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, camrelizumab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05738057 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a combined treatment approach for patients with advanced and unresectable intrahepatic cholangiocarcinoma (ICC) using drug-eluting bead-transarterial chemoembolization (D-TACE), gemcitabine, cisplatin, and a PD-1 antibody. The study aims to determine the effectiveness of this combination in converting unresectable tumors to resectable ones and to evaluate the safety of the treatment regimen. Participants will receive D-TACE along with chemotherapy and immunotherapy, followed by a 24-month follow-up to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed unresectable intrahepatic cholangiocarcinoma and a life expectancy of more than three months.

Not a fit: Patients who have previously undergone interventional therapy or have severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could potentially convert unresectable ICC into a resectable form, improving patient outcomes.

How similar studies have performed: While the specific combination of therapies in this trial may be novel, similar approaches using chemotherapy and immunotherapy have shown promise in other studies.

Eligibility criteria

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:

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.

Where this trial is running

Guangzhou, Guangdong

• The Third Affiliated Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Hua Li, MD&PhD

Conditions Unresectable Intrahepatic Cholangiocarcinoma