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

NCT ID: NCT05738057

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2026-03-01

Brief 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.

Conditions

Unresectable Intrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

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

Gemcitabine Injection

Intervention Type: DRUG

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

Cisplatin injection

Intervention Type: DRUG

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

Cisplatin-Eluting Beads

Intervention Type: DRUG

used for D-TACE

D-TACE

Intervention Type: PROCEDURE

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

Interventions

Camrelizumab

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

Intervention Type: DRUG

Gemcitabine Injection

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

Intervention Type: DRUG

Cisplatin injection

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

Intervention Type: DRUG

Cisplatin-Eluting Beads

used for D-TACE

Intervention Type: DRUG

D-TACE

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hua Li

OTHER

Sponsor Role: lead

Responsible Party

Hua Li

Director, Hepatic Surgery Department of Third Affiliated Hospital, Sun Yat-Sen University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yang Yang, MD&PhD

Role: STUDY_CHAIR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hua Li, MD&PhD

Role: CONTACT

lihua100@yeah.net

+8613060975202

Linsen Ye, MD&PhD

Role: CONTACT

ye_linsen@163.com

+8618520788663

Other Identifiers

[2023]02-116-01

Identifier Type: -

Identifier Source: org_study_id