Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE

NCT06607276 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-SR-571
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 4

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 biliary tract malignancies. However, the surgical resection rate and long-term survival rate after surgery are still not satisfactory, and the high postoperative recurrence rate is an important factor affecting the long-term survival of patients. Therefore, there is an urgent need to explore new postoperative adjuvant treatment plans to reduce postoperative tumor recurrence, which is of great significance for extending the survival of patients with biliary tract malignancies. In the NCCN and CSCO guidelines, capecitabine is listed as a category I recommendation for adjuvant treatment of biliary tract malignancies (BTC). However, in clinical practice, the use of capecitabine or tegafur for postoperative patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate. Therefore, there is still a huge unmet need in the clinical adjuvant treatment after surgery for biliary tract malignancies. Based on the above background, we plan to carry out a randomized, open, and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery, and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma.

Conditions

Cholangiocarcinoma Cancer; Adebrelimab (SHR-1316)

Keywords

Adebrelimab; capecitabine; Cholangiocarcinoma; Adjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• one year recurrence free survival rate (1-year RFS)

  1-year RFS refers to the proportion of patients who have not experienced disease recurrence or death within one year from randomization.

  1 year

Secondary Outcomes (3)

• overall survival (OS)

  3 year

• Recurrence free survival (RFS)

  2 year

• minimal residual disease (MRD)

  2 year

Study Arms (2)

Adebrelimab and capecitabine

EXPERIMENTAL

Drug: Adebrelimab and capecitabine

capecitabine

ACTIVE COMPARATOR

Drug: capecitabine

Interventions

Adebrelimab and capecitabine DRUG

Adebrelimab: 1200mg, IV, q3w for one year; capecitabine:1250mg/m2, po, bid,d1-14, q3w, for 6-8 cycles

Adebrelimab and capecitabine

capecitabine DRUG

capecitabine:1250mg/m2, po, bid,d1-14, q3w, for 6-8 cycles

capecitabine

Eligibility Criteria

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

You may qualify if:

• Patients must sign an informed consent form;
• Ages 18-75, both genders eligible;
• ECOG performance status score (PS score) of 0 or 1;
• 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 \> 5 cm, multiple tumors, liver capsule breach, vascular invasion, regional lymph node metastasis) Hilar cholangiocarcinoma (Tumor invasion into surrounding tissues, vascular invasion, regional lymph node metastasis)
• No evidence of recurrence or metastatic lesions on imaging within 28 days prior to randomization;
• No prior systemic anti-cancer therapy (including radiotherapy, chemotherapy, targeted therapy, immunotherapy) before curative resection;
• 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);
• Life expectancy of more than 6 months.

You may not qualify if:

• Pathological diagnosis of mixed hepatocellular carcinoma and other non-hepatic extra-bile duct cholangiocarcinoma or ampulla of Vater malignant tumor components;
• History of prior systemic treatment;
• History of or concurrent other malignancies, excluding non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma that have been adequately treated;
• 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;
• 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;
• 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;
• Severe cardiopulmonary or renal dysfunction;
• 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;
• 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;
• HBV DNA \>2000 IU/ml, active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection);
• Active infection requiring systemic treatment;
• Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
• History of psychiatric medication abuse, alcoholism, or drug addiction;
• History of allergy to study medication;
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Jinling Hospital, China: collaborator

Study Sites (4)

Jinling Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210002, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 240000, China

NOT YET RECRUITING

Yancheng NO.1 People's Hospital

Yancheng, Jiangsu, 280000, China

NOT YET RECRUITING

Related Publications (1)

• Cheng Y, Zhang Y, Li C, Li X. Adebrelimab plus capecitabine versus capecitabine monotherapy for adjuvant treatment of high-risk resected cholangiocarcinoma (ACHIEVE): protocol for a phase II, multicentre, randomised controlled trial. BMJ Open Gastroenterol. 2025 Jul 30;12(1):e001892. doi: 10.1136/bmjgast-2025-001892.

  PMID: 40738506 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Xiangcheng Li, Prof. M.D.

CONTACT

86 18951999088; drlixc@163.com

Changxian Li, Prof. M.D.

CONTACT

86 18761854602; doclicx20@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2027
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

CN (4)