Adebrelimab Combined With Capecitabine for Adjuvant Therapy in Cholangiocarcinoma With High-risk Recurrence Post-surgery

Phase 2

Not yet recruiting

• Conditions: Cholangiocarcinoma Cancer; Adebrelimab (SHR-1316)
• Interventions: Drug: Adebrelimab and capecitabine; Drug: capecitabine

• Registration Number: NCT06607276
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

Biliary tract malignancies (BTC) are malignant tumors that originate from the epithelium of the bile ducts. Currently, the optimal treatment for biliary tract malignancies is radical surgical resection. In recent years, with the advancement of imaging technology and surgical techniques, there has been certain progress in the diagnosis and treatment of biliar...

Detailed Description

Postoperative adjuvant therapy for biliary system tumors has long lacked a universally recognized standard regimen. The BILCAP trial results showed a survival benefit with adjuvant therapy. The BILCAP study filled the gap in the field of postoperative adjuvant therapy for biliary system tumors. In the study, the median overall survival (OS) in the capecitabi...

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study Start: 2024-09-20
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2026-09-20
• Study Completion: 2027-09-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

1. Patients must sign an informed consent form;

2. Ages 18-75, both genders eligible;

3. ECOG performance status score (PS score) of 0 or 1;

4. Patients with histologically confirmed cholangiocarcinoma (including intrahepatic cholangiocarcinoma and hilar cholangiocarcinoma), who have undergone R0 resection and have high-risk factors for recurrence;

   High-risk factors are defined as follows:

   Intrahepatic cholangiocarcinoma (single tumor >5cm, multiple tumors within the liver, tumor penetration of the liver capsule or direct involvement of surrounding tissue, vascular invasion, regional lymph node metastasis) Hilar cholangiocarcinoma (tumor infiltration of surrounding tissue or adjacent liver parenchyma, vascular invasion, regional lymph node metastasis)

5. No evidence of recurrence or metastatic lesions on imaging within 28 days prior to randomization;

6. No prior systemic anti-cancer therapy (including radiotherapy, chemotherapy, targeted therapy, immunotherapy) before curative resection;

7. Laboratory test values within 7 days prior to the first dose of study medication meet the following criteria:

   Complete blood count: (except for hemoglobin, no blood transfusion or use of granulocyte colony-stimulating factor [G-CSF], no medication correction within 2 weeks prior to screening):

   Absolute neutrophil count ≥1.5×109/L; Platelets ≥75×109/L; Hemoglobin ≥90 g/L;

   Biochemical tests:

   Serum albumin ≥30g/L; Serum total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN; Serum creatinine ≤1.5×ULN; or Cr clearance rate >50 mL/min International normalized ratio (INR) ≤1.2 or prothrombin time (PT) exceeding the normal control range by ≤2 seconds; Urine protein <2+ (if urine protein ≥2+, a 24-hour (h) urine protein quantification can be performed, and a 24h urine protein quantification of <1.0g is eligible for enrollment);

8. Life expectancy of more than 6 months.

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Exclusion Criteria

1. Pathological diagnosis of mixed hepatocellular carcinoma and other non-hepatic extra-bile duct cholangiocarcinoma or ampulla of Vater malignant tumor components;
2. History of prior systemic treatment;
3. History of or concurrent other malignancies, excluding non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma that have been adequately treated;
4. Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; history of active tuberculosis infection more than 1 year prior to enrollment without proper anti-tuberculosis treatment or tuberculosis is still active;
5. History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis;
6. Requirement for long-term systemic corticosteroids (dosage equivalent to >10mg prednisone/day) or any other form of immunosuppressive treatment. Subjects using inhaled or topical corticosteroids may be included;
7. Severe cardiopulmonary or renal dysfunction;
8. Inadequately controlled arterial hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) (based on the average of ≥2 blood pressure readings), allowing the achievement of the above parameters through the use of antihypertensive treatment; history of hypertensive crisis or hypertensive encephalopathy;
9. Within 3 months prior to enrollment, significant clinical bleeding symptoms or a clear tendency to bleed; abnormal coagulation function (PT >14s), tendency to bleed, or undergoing thrombolytic or anticoagulant therapy;
10. HBV DNA >2000 IU/ml, active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection);
11. Active infection requiring systemic treatment;
12. Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
13. History of psychiatric medication abuse, alcoholism, or drug addiction;
14. History of allergy to study medication;
15. Other factors deemed by the investigator to potentially affect subject safety or trial compliance. Such as severe diseases requiring concurrent treatment (including psychiatric diseases), severe laboratory test abnormalities, or other family or social factors.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adebrelimab and capecitabine	Adebrelimab and capecitabine	-
capecitabine	capecitabine	-

Primary Outcome Measures

Name	Time	Method
1y-RFS	1 year	It refers to the proportion of patients who have not experienced disease recurrence or death due to disease progression within one year from the start of randomization.