Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma

NCT06298968 | Recruiting Phase 2

• 1 other identifier: NFEC-2024-074
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

In this phase 2 study, the investigators aim to evaluate the efficacy and safety of combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

Lenvatinib; Adebrelimab; gemcitabine; cisplatin

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1

  From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years

Secondary Outcomes (5)

• The disease control rate (DCR)

  From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

• Duration of response (DOR)

  From the first documentation of CR or PR to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)

• The median progression free survival time (mPFS)

  From date of first dose of study drug to the date of first documentation of disease progression (up to approximately 3 years)

• The median overall survival time (mOS)

  From the start date of the Treatment Phase until date of death from any cause (up to approximately 3 years)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  From the start date of the Treatment Phase until date of death from any cause (up to approximately 3 years)

Study Arms (1)

Combined therapy using GC, Lenvatinib and Adebrelimab

EXPERIMENTAL

GC chemotherapy every 3 weeks,with a total of 6 cycles. Lenvatinib 8 mg once daily (QD) oral dosing. Adebrelimab 1200mg intravenously every 3 weeks.

Drug: combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab

Interventions

combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab DRUG

Gemcitabine (1000mg/m²) and cisplatin (25mg/m²) on day1 and 8 every 3 weeks, with a total of 6 cycles. Lenvatinib 8 mg once daily (QD) oral dosing, continuous use for 2 years. Adebrelimab 1200mg intravenously every 3 weeks, continuous use for 2 years.

Combined therapy using GC, Lenvatinib and Adebrelimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be required to sign an informed consent form;
• Age 18-75 years old, male or female;
• Eastern Cooperative Oncology Group (ECOG) fitness status score (PS score) 0-1;
• Child-Pugh score A;
• Histopathologically confirmed intrahepatic cholangiocarcinoma; consent to provide previously stored tumor tissue specimens or fresh biopsy tumor lesions;
• Advanced and unresectable ICC patients;
• The expected survival is longer than 12 weeks;
• At least 1 measurable liver lesion or non-liver lesion (according to RECIST 1.1);
• Functional indicators of vital organs meet the following requirements a Neutrophils ≥1.5\*109/L; platelets≥100\*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; b Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal value(ULN), T3, T4 are in the normal range; c bilirubin ≤ 2 times ULN; Alanine aminotransferase （ALT） and Aspartate aminotransferase （AST） ≤ 2 times ULN; serum creatinine ≤ 1.5 ULN, creatinine clearance rate ≥ 60ml / min;
• Non-lactating or pregnant women, contraception during or after 3 months of treatment.

You may not qualify if:

• Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer and other non-cholangiocarcinoma malignant tumor components;
• Patients who have received previous treatment with PD1 antibody, programmed death ligand -1 （PD-L1） antibody or cytotoxic T lymphocyte-associated antigen-4 （CTLA4） antibody;
• With other malignant tumors, except for fully treated 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;
• 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;
• Previous interstitial lung disease, or (non-infectious) pneumonia and need oral or intravenous steroid therapy;
• Long-term systemic hormones (dose equivalent to \>10 mg prednisone/day) or any other form of immunosuppressive therapy are required. Subjects using inhaled or topical corticosteroids may be enrolled;
• Severe cardiopulmonary and renal dysfunction;
• 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 (PT\>14s), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
• Hepatitis B virus （HBV） DNA\>2000 copies/ml, hepatitis C virus （HCV） RNA\>1000;
• Significant clinically significant bleeding symptoms or a clear tendency to appear within 6 months prior to enrollment;
• Active infections requiring systemic treatment;
• Human immunodeficiency virus (HIV) positive;
• History of psychotropic substance abuse, alcohol abuse or drug abuse;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Jinzhang Chen, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengya Zang

CONTACT

86-20-62787430; zangmy@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

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: April 26, 2024
• Primary Completion: February 25, 2025
• Study Completion (Estimated): February 25, 2027
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)