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

NCT05738057 | Recruiting Phase 2

• 1 other identifier: [2023]02-116-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Conversion rate

  Rate of unresectable ICC convert to resectable in combination therapy

  12 months

Secondary Outcomes (8)

• Incidence of adverse events

  12 months

• Objective Response Rate (ORR)

  12 months

• Deepness of response (DpR)

  12 months

• Disease control rate (DCR)

  12 months

• Rate of R0 resection

  12 months

Study Arms (1)

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

EXPERIMENTAL

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

Camrelizumab DRUG

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

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

Gemcitabine Injection DRUG

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

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

Cisplatin injection DRUG

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

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

Cisplatin-Eluting Beads DRUG

used for D-TACE

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

D-TACE PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, male or female;
• Histopathologically confirmed intrahepatic cholangiocarcinoma;
• Tumor is unresectable assessed by the expert group (R0 resection CANNOT be achieved) and the life expectancy is more than 3 months;
• Presence of at least one measurable lesion assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Child-Pugh score ≤ 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;
• The patient must be required to sign an informed consent form;

You may not qualify if:

• 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;
• 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;
• 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;
• Active infection requiring systemic therapy;
• Human immunodeficiency virus (HIV) positive;
• 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;
• Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
• 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;
• Pregnant or lactating women;
• Participated in other trials within the last 4 weeks;
• Has a history of allergy to platinum;
• 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.

Sponsors & Collaborators

• Hua Li: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yang Yang, MD&PhD

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Hua Li, MD&PhD

CONTACT

+8613060975202; lihua100@yeah.net

Linsen Ye, MD&PhD

CONTACT

+8618520788663; ye_linsen@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Hepatic Surgery Department of Third Affiliated Hospital, Sun Yat-Sen University

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 21, 2023
• Study Start: June 30, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)