About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Neoantigen Vaccine plus Capecitabine
Combination product1. Capecitabine.Twice a day, 30 minutes after breakfast, swallow with water, continue for 2 weeks, then stop for 1 week, constitutes one cycle; three weeks make one cycle, lasting for 8 cycles. 2. Neoantigen Vaccine . Every 3 weeks, once every 21 days, for 4 to 8 cycles. The injection is administered on the first day after cessation of capecitabine. Treatment can last for up to 6 months without occurrences such as the researcher determining no further clinical benefit, intolerable toxic reactions, initiation of new anti-tumor treatment, withdrawal of informed consent, loss to follow-up, death, or other circumstances specified in the protocol that require treatment termination.
Treatment groups
Trial 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.
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.
Secondary outcomes
1 year Overall Survival (OS) rate
The percentage of patients who are still alive one year after the start of the study.
Recurrence-free survival (RFS)
Recurrence-free survival (RFS) is defined as the time from initiation of treatment with the first dose to the first documented recurrence (according to RECIST 1.1 criteria) or until the patient's death from any cause, whichever occurs first.
Other outcomes
Biomarker analysis (changes in immune cells and regulating immune-related molecules and immune-related indicators in patients before and after treatment)
Assess the effects of new antigen vaccines on activating immune cells and regulating immune-related molecules, as well as changes in immune-related indicators in patients before and after treatment.
Sponsors and contacts
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Yongyi Zeng
Lead sponsor
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Sponsor institution