Clinical Efficacy of Tumour Treatment Vaccine (TTV) Combined With PD-1 in the Treatment of Relapsed Refractory Advanced Solid Tumours

Launched by WUXI PEOPLE'S HOSPITAL · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with advanced solid tumors, which are types of cancer that have spread and are hard to treat. The trial combines a tumor treatment vaccine (TTV) with a medication that targets a specific protein called PD-1. Researchers want to see if this combination can help patients whose cancer has come back or who haven't responded to standard therapies.

To qualify for the trial, participants need to be between 18 and 75 years old and have a confirmed diagnosis of an advanced solid tumor that hasn't improved with other treatments. They should also have at least one measurable tumor for evaluation. It’s important to note that participants need to agree to use birth control if they are of childbearing age, and they will need to sign a consent form to take part. Those who join can expect regular check-ups and monitoring during the study. This trial is currently looking for volunteers, so anyone interested should talk to their doctor for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female aged 18-75 years;
• • 2. Subjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy;
• • 3. Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
• • 4. ECOG score of 0-2, lifespan \> 12 weeks;
• • 5. Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
• • 6. Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
• Exclusion Criteria:
• • 1. The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
• • 2. White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
• • 3. Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
• • 4. HIV, HBV and HCV positive;
• • 5. Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
• • 6. Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months;
• • 7. Patients are on anticoagulation or have severe coagulopathy (APTT\>70);
• • 8. Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
• • 9. Patients were infected with covid-19 within 2weeks prior to investigational drug administration;
• • 10. Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
• • 11. Subjects in other conditions that are considered unsuitable for this study by the investigator.