Lenvatinib and Adebrelimab Combined With GEMOX in the Perioperative Treatment of Potentially Resectable Intrahepatic Cholangiocarcinoma

NCT ID: NCT06417606

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2025-05-30

Brief Summary

A single-arm, prospective clinical study was conducted to enroll 20 subjects. Each subject was treated with oral Lenvatinib + Adebrelimab + GEMOX (gemcitabine + oxaliplatin). The treatment phase before surgery was 3 cycles, and the evaluation was performed every 2 cycles. The evaluation was repeated before surgery, and the decision of surgery was made according to the evaluation results.

To evaluate the efficacy and safety of Lenvatinib and Adebrelimab combined with GEMOX in the perioperative treatment of potentially resectable intrahepatic cholangiocarcinoma.

Conditions

Intrahepatic Cholangiocarcinoma

Study Design

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

Study Groups

Lenvatinib and Adebrelimab Combined With GEMOX（Gemcitabine and oxaliplatin）

Lenvatinib（oral，12mg once daily if body weight ≥60Kg; Body weight \< 60Kg, 8mg/ day）； Adebrelimab（intravenous drip，1200mg once every 3 weeks）； GEMOX（intravenous drip，Gemcitabine 1000mg/m2, 2 times every 3 weeks d1+d8; intravenous drip，Oxaliplatin, 100mg/m2, was given every 3 weeks）

Group Type: EXPERIMENTAL

Lenvatinib

Intervention Type: DRUG

Lenvatinib（oral，12mg once daily if body weight ≥60Kg; Body weight \< 60Kg, 8mg/ day）； Adebrelimab（intravenous drip，1200mg once every 3 weeks）； GEMOX（intravenous drip，Gemcitabine 1000mg/m2, 2 times every 3 weeks d1+d8; intravenous drip，Oxaliplatin, 100mg/m2, was given every 3 weeks）

Interventions

Lenvatinib

Lenvatinib（oral，12mg once daily if body weight ≥60Kg; Body weight \< 60Kg, 8mg/ day）； Adebrelimab（intravenous drip，1200mg once every 3 weeks）； GEMOX（intravenous drip，Gemcitabine 1000mg/m2, 2 times every 3 weeks d1+d8; intravenous drip，Oxaliplatin, 100mg/m2, was given every 3 weeks）

Intervention Type: DRUG

Other Intervention Names

Adebrelimab; GEMOX（Gemcitabine and oxaliplatin）

Eligibility Criteria

Inclusion Criteria

• Voluntarily participated in this study, signed informed consent, aged 18-80 years
• Patients with locally advanced intrahepatic cholangiocarcinoma: (meet at least one of the following) A, the number of intrahepatic tumors was 2-3 B, the intrahepatic tumor is single but >5cm in diameter C, the tumor was close to the 1/2 grade branch of the hepatic pedicle, making RO resection difficult D. Lymph node metastasis: MRI or PET/CT suggested regional lymph node metastasis
• The WHO/ECOG PS score was 0-1
• Imaging examination (CT/MRI/PET-CT) showed no distant metastasis
• Child-Pugh grade: A (≤6 points)
• Expected survival time ≥6 months
• No previous systemic treatment for hepatocellular carcinoma, including chemotherapy, targeted therapy, immunotherapy, etc. Patients who had undergone previous curative surgery or curative ablation were allowed, except those who had a recurrence within 2 years after curative surgery and those who had received other previous local treatment
• If you have hepatitis B virus (HBV) infection, such as HBsAg positive, you need to test HBV-DNA, and HBV-DNA should be less than 500IU/mL (; Patients with HBV-DNA of more than 500 IU per milliliter received antiviral therapy (only nucleoside agents such as entecavir, tenofovir dipivoxil fumarate, and tenofovir propofol fumarate tablets) for at least 1 week before randomization and had a decrease in viral copy number by a factor of more than 10. For patients with HBV infection, antiviral therapy should be received throughout the study period. Patients who are positive for hepatitis C virus (HCV) -RNA must receive antiviral therapy according to treatment guidelines
• Organs and bone marrow are sufficiently functional, defined as follows:

1. hemoglobin ≥9g/dL

2. absolute neutrophil count ≥1.5 × 109/L

3. platelet count ≥ 100 × 109/L

4. serum bilirubin ≤2.0× upper limit of normal (ULN); This condition does not apply to patients with proven Gilbert's syndrome. Any clinically significant biliary obstruction had to be relieved prior to enrollment in the study.

5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be ≤2.5×ULN. For patients with liver metastases, ALT and AST should be ≤5 × ULN.

Exclusion Criteria

• The investigator deemed the subject unfit to participate in the study
• Have active autoimmune disease or a history of autoimmune disease with possible recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism)
• Use of immunosuppressant or systemic hormone therapy to achieve immunosuppression within 2 weeks before treatment (dose >10mg/ day of prednisone or other effective hormones)
• patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or white blood cell count >15×109/L during screening; Therapeutic antibiotics, administered orally or intravenously, were given within 2 weeks before randomization
• Patients with innate or acquired immune deficiency (e.g., HIV infection)
• History of other primary malignancies, with the exception of malignancies treated with curative treatment, known absence of active disease ≥5 years before the first study intervention, and low potential risk of recurrence; Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or lentigo maligna that has received potentially curative treatment; Or carcinoma in situ that has been adequately treated without evidence of disease
• Patients with clinically significant bleeding symptoms or a clear bleeding tendency within 6 months before treatment, such as gastrointestinal bleeding, severe esophagogastric varices, hemorrhagic gastric ulcer, or angiitis, can be reexamined if fecal occult blood is positive at baseline, and if it is still positive after reexamination, gastroscopy is required
• Known inherited or acquired bleeding (e.g. coagulopathy) or thrombophilia, such as in patients with hemophilia, coagulation disorders, thrombocytopenia, etc.; Currently receiving full-dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use such as low-dose aspirin is allowed)
• Known allergies to any study drug or excipients
• Participate in other drug clinical trials within 4 weeks before randomization
• Pregnant or lactating women
• Other factors considered by the investigator to be unsuitable for participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhiyong Huang

OTHER

Sponsor Role: lead

Responsible Party

Zhiyong Huang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhiyong Huang

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Tongji Hospital

Wuhan, , China

Countries

China

Central Contacts

Zunyi Zhang

Role: CONTACT

zunyizhangtjmu@163.com

86-15827413728

Guan Tan

Role: CONTACT

d202382316@hust.edu.cn

86-15971812255

Facility Contacts

Zunyi Zhang

Role: primary

zunyizhangtjmu@163.com

86-15827413728

Guan Tan

Role: backup

d202382316@hust.edu.cn

86-15971812255

Other Identifiers

IEC-ZN-01-AF 09

Identifier Type: -

Identifier Source: org_study_id