Status:

RECRUITING

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

Lead Sponsor:

Wuxi People's Hospital

Conditions:

Cancer

PD-L1 Gene Mutation

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

This study is intended to investigate the clinical efficacy of TTV vaccine combined with PD-1/PD-L1 inhibitor in the treatment of relapsed and refractory advanced solid tumours from a clinical perspec...

Detailed Description

The innovative invention of Tumour Treatment Vaccine (TTV) has been verified in previous studies that the TTV vaccine can play a good role in enhancing the anti-tumour effect of immune checkpoint inhi...

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.

Key Trial Info

Start Date :

May 7 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06430502

Start Date

May 7 2024

End Date

December 1 2027

Last Update

May 28 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Wuxi People's Hospital

Wuxi, Jiangsu, China, 214043