Neoantigen Vaccine Plus Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma After Radical Resection

Yongyi Zeng1 site in 1 country10 target enrollmentMay 6, 2024

ConditionsIntrahepatic Cholangiocarcinoma

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Intrahepatic Cholangiocarcinoma
Sponsor: Yongyi Zeng
Enrollment: 10
Locations: 1
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse events (TRAEs), Serious adverse events (SAEs), and grade 3 or higher TRAEs.
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a single-arm, open-label, exploratory clinical trial, with the primary objective to evaluate the efficacy and safety of the Neoantigen Vaccine plus capecitabine for the treatment of high-intermediate risk recurrent intrahepatic cholangiocarcinoma

Registry

clinicaltrials.gov

Start Date

May 6, 2024

End Date

May 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Yongyi Zeng

Responsible Party

Sponsor Investigator

Principal Investigator

Yongyi Zeng

Director

Meng Chao Hepatobiliary Hospital of Fujian Medical University

Eligibility Criteria

Inclusion Criteria

•Sign a written informed consent form and be able to comply with the scheduled visits and related procedures as per the protocol;
•Age ≥18 years and ≤75 years, any gender;
•Confirmed pathologically as a patient with intrahepatic cholangiocarcinoma;
•Not receiving neoadjuvant therapy, underwent surgical resection, and pathology confirmed high-risk factors for recurrence: positive margins, lymph node metastasis, vascular invasion, nerve invasion, diameter \>5cm, classified as stage IB-IIIB according to AJCC TNM (8th edition, 2017), and have not yet received systemic adjuvant therapy;
•Child-Pugh score grade A;
•ECOG score of 0-1;
•If infected with hepatitis B virus (HBV), such as HBsAg positive, HBV-DNA must be tested and HBV-DNA should be \<2000 IU/mL (if the research center uses copy/mL as the detection unit, then it must be \<104 copy/mL), and must have received at least 1 week of anti-HBV treatment before the start of the study and willing to undergo antiviral treatment throughout the study period; HCV RNA positive patients must receive antiviral treatment according to the treatment guidelines;
•The subjects are required to provide fresh or archived tumor tissue samples as requested in the post-operative protocol for use in gene sequencing and peptide gel vaccine preparation;
•Expected survival period ≥12 weeks;
•Has sufficient organ and bone marrow function, has not received blood transfusion or hematopoietic growth factor within 14 days before screening. Laboratory test values meet the following requirements, as follows: a. Hematology: Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelet count (PLT) ≥50×10\^9/L; Hemoglobin (HGB) ≥90g/L b. Liver function: Total bilirubin (TBIL) ≤3×upper limit of normal value (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤5×ULN; Serum albumin ≥30g/L c. Renal function: Serum creatinine (Cr) ≤1.5×ULN, or for subjects with creatinine \>1.5×ULN, creatinine clearance rate (CCr) ≥45 mL/min (Cockcroft-Gault formula); Urine routine results show urine protein \<2+; For subjects with urine protein ≥2+ on baseline urine routine testing, 24-hour urine collection should be performed and 24-hour urine protein quantification \<1 g d. Coagulation function: International normalized ratio (INR) or APTT ≤1.5×ULN;

Exclusion Criteria

•Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, hilar cholangiocarcinoma, and gallbladder cancer;
•Patients with other active malignant tumors other than intrahepatic cholangiocarcinoma within 5 years or simultaneously. Patients with localized tumors that have been cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostatic carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included;
•Currently with interstitial pneumonia or interstitial lung disease, or with a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment in the past, or other possible interferences with the judgment and treatment of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with active pneumonia or severe lung function impairment shown by chest CT during screening; active tuberculosis;
•Presence of active autoimmune diseases or a history of autoimmune diseases that may relapse \[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients controlled only by hormone replacement therapy can be included)\]; patients with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type 1 diabetes mellitus treated with insulin, or patients with asthma who have completely resolved in childhood and require no intervention as adults can be included; patients with asthma requiring bronchodilators for medical intervention cannot be included;
•Within 2 weeks before the start of the study, use of immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \>10mg/day prednisone or other equivalent glucocorticoids);
•Patients with active infections, with unexplained fever ≥38.5°C within 1 week before the start of the study, or with a baseline white blood cell count \>15×10\^9/L;
•Patients with congenital or acquired immune deficiency (e.g., HIV infection);
•Within 4 weeks before the first dose, received or planned to receive live or attenuated live vaccines during the study;
•Within 6 months before the start of the study, significant clinical bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, etc. If positive for occult blood in stool at baseline, it can be retested; if still positive after retesting, endoscopy is required;
•Known existing hereditary or acquired bleeding disorders (e.g., hemophilia patients), coagulation disorders, thrombocytopenia, etc.); currently receiving full-dose oral or injected anticoagulants or thrombolytics for therapeutic purposes (prophylactic use of low-dose aspirin is allowed, etc.);

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse events (TRAEs), Serious adverse events (SAEs), and grade 3 or higher TRAEs.

Time Frame: Up to 12 weeks after the last use of the study drug

Safety parameters in this study include clinical symptoms, vital signs, physical examinations, laboratory tests (complete blood count, urinalysis, blood chemistry, coagulation function, etc.). Adverse events (AEs) observed are evaluated according to the NCI-CTCAE version 5.0, including type, incidence, severity, onset and end time, whether they are serious adverse events, and their relationship to the investigational drug.