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

Unresectable Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738057
• Other study ID #: [2023]02-116-01
• Status: Recruiting
• Phase: Phase 2
• Start date: June 30, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: November 2023
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Hua Li, MD&PhD
• Phone: +8613060975202
• Email: lihua100[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Unresectable Intrahepatic Cholangiocarcinoma

Intervention

Drug:
• Camrelizumab
200mg on day1 of every 3 weeks, starting on day1 of cycle1
• Gemcitabine Injection
1000mg/m2 on day1 & day8 of every 3 weeks, starting on day1 of cycle 1
• Cisplatin injection
25mg/m2 on day1 & day8 of every 3 weeks, starting on day1 of cycle 1
• Cisplatin-Eluting Beads
used for D-TACE

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

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Hua Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion rate	Rate of unresectable ICC convert to resectable in combination therapy	12 months
Secondary	Incidence of adverse events	Rate of participants with treatment-related adverse events as assessed by CTCAE v4.0	12 months
Secondary	Objective Response Rate (ORR)	ORR according to RECIST 1.1 using investigator assessment	12 months
Secondary	Deepness of response (DpR)	DpR according to RECIST 1.1 using investigator assessment	12 months
Secondary	Disease control rate (DCR)	DCR according to RECIST 1.1 using investigator assessment	12 months
Secondary	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	12 months
Secondary	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.	12 months
Secondary	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	12 months
Secondary	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	12 months