A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable ICC

NCT06925516 | Recruiting Phase 2

• 1 other identifier: SYSKY-2025-012-02
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the efficacy and safety of Apatinib and Adebrelimab in Combination With chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC)

Conditions

Intrahepatic Cholangiocarcinoma (Icc)

Keywords

unresectable intrahepatic cholangiocarcinoma; cholangiocarcinoma; GEMOX chemotherapy; Antineoplastic Agents; Tyrosine kinase inhibitors

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  the objective response rate (ORR) of advanced ICC patients who progressed after standard treatment with Adebrelimab and apatinib plus GEMOX.

  12 months

Secondary Outcomes (3)

• Adverse Events

  from the first drug administration to within 30 days for the last Adebrelimab dose

• progression free survival (PFS)

  up to 24 months

• overall survival (OS)

  up to 24 months

Study Arms (1)

Apatinib and Adebrelimab in Combination With chemotherapy

EXPERIMENTAL

Adebrelimab (IV 1200mg q3w) and apatinib (PO 250mg qd) plus GEMOX (up to 6 cycles) in 21day cycles

Drug: Apatinib and Adebrelimab in Combination With chemotherapy

Interventions

Apatinib and Adebrelimab in Combination With chemotherapy DRUG

Patients would receive Adebrelimab (IV 1200mg q3w) and apatinib (PO 250mg qd) plus GEMOX (up to 6 cycles) in 21day cycles. Apatinib and Adebrelimab would be maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years.

Apatinib and Adebrelimab in Combination With chemotherapy

Eligibility Criteria

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

You may qualify if:

• \. Provided informed consent and sign the informed consent form;
• \. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
• \. Histologically or cytologically confirmed ICC;
• \. The patient is not a candidate for surgery, or the disease has progressed after prior surgery and/or local treatment.
• \. No previous systematic treatment for advanced ICC. Exceptions include patients who relapsed more than 6 months after adjuvant chemotherapy following radical resection. Local regional therapy (including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic arterial infusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) must have been completed at least 4 weeks prior to baseline radiological scanning, and any toxicity (except alopecia) induced by local regional therapy must have resolved to ≤ Grade 1 in accordance with National Cancer Institute - Common Terminology Criteria for Adverse Event version 5.0 (NCI-CTCAE v5.0);
• \. Have at least one measurable lesion (in accordance with RECIST v1.1, major diameter ≥ 10 mm of the measurable lesion in spiral CT scan or short diameter of swollen lymph node ≥ 15 mm; the lesion with previous local therapy can be used as target lesion after the progression is confirmed in accordance with RECIST v1.1)
• \. Child-Pugh class: Grade A;
• \. ECOG-PS score: 0-1;
• \. With a life expectancy of ≥ 12 weeks;
• \. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;
• \. If subjects have active hepatitis B (HBV) infection: HBV- deoxyribonucleic acid (DNA) must be \< 500 IU/mL (or must be \< 2500 copy/mL if copy/mL is the only unit available in the study site) and are willing to receive antiviral therapy throughout the study (treatment in accordance with local standard of care, e.g., entecavir);
• \. Women of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last study drug administration. A negative serum pregnancy test (HCG) must be confirmed within 7 days before starting study treatment. Lactating women are excluded;
• \. Men with female partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable contraception from the time of signing informed consent until at least 120 days after the last study drug administration. Men must also agree not to donate sperm during this period. For men whose partners are pregnant, condom use is required without additional contraception;

You may not qualify if:

• \. Known hepatocellular carcinoma, Combined Hepatocellular and Intrahepatic Cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, fibrolamellar carcinoma of liver;
• \. Other active malignant tumor except ICC within 5 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled;
• \. Planning to or previously received organ or allogenic bone marrow transplantation;
• \. Treatment of other investigational product(s) within 28 days prior to the start of study treatment;
• \. Previous treatment with Immune Checkpoint Inhibitors: Prior use of any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints), including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies (including topical use).
• \. Moderate-to-severe ascites with clinical symptoms, i.e., requiring therapeutic puncture or drainage, or Child-Pugh score \>2, except the subjects with small amount of ascites in radiological examination but free from clinical symptoms; uncontrolled or moderate to severe pleural effusion, pericardial effusion.
• \. History of gastrointestinal bleeding within 6 months prior to the start of study treatment or clear tendency of gastrointestinal bleeding;
• \. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment;
• \. Known genetic or acquired hemorrhage (e.g., coagulation dysfunction) or thrombotic tendency, for example, subject with hemophilia; current or recent (within 10 days prior to the start of study treatment) use of full-dose of oral or intravenous anticoagulant or thrombolytic drug for the purpose of treatment (preventive use of low-dose aspirin or low molecular weight heparin is allowed);
• \. Current or recent (within 10 days prior to the start of study treatment) use of aspirin (\> 325 mg/day, maximum dose for antiplatelet) or dipyridamole, ticlopidine, clopidogrel and cilostazol;
• \. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment, for example, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism;
• \. Cardiac clinical symptom or disease that is not well controlled;
• \. Hypertension that cannot be well controlled through antihypertensive drugs, allowing to reach the above parameters by the use of antihypertensive therapy; previous hypertensive crisis or hypertensive encephalopathy;
• \. Major vascular disease within 6 months prior to the start of study treatment (for example, aortic aneurysm requiring surgical repair or peripheral arterial thrombosis in recent days); Serious, unhealed or splitting wound and active ulcer or untreated bone fracture; Major surgical therapy within 4 weeks prior to the start of study treatment (except diagnosis), or planned major surgery during the study;
• \. Evidence on intraperitoneal pneumatosis that can not be explained by puncture or recent surgery;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Interventions

apatinib; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Changzhen Shang, M.D, PhD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changzhen Shang, M.D, PhD

CONTACT

+86-20-3407 0701; shchzh2@mail.sysu.edu.cn

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: April 6, 2025
• First Posted: April 13, 2025
• Study Start: January 22, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)