Combining a Tumor Treatment Vaccine with PD-1 therapy for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a Tumor Treatment Vaccine (TTV) when used alongside PD-1/PD-L1 inhibitors in patients with relapsed and refractory advanced solid tumors. Previous research has shown that the TTV vaccine can enhance the anti-tumor effects of immune checkpoint inhibitors, achieving a tumor suppression rate of nearly 76%. The study aims to evaluate the clinical efficacy of this combination therapy from a clinical perspective, focusing on patients who have not responded to standard treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Wuxi People's Hospital
  Wuxi, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Peihua Lu
• Email: lphty1_1@163.com
• Phone: 0510-85350495

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Intratumoral chemotherapy for advanced solid tumors

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• Using low-dose chemotherapy with controlled blood sugar to treat advanced solid tumors

  This study is testing if giving low-dose chemotherapy while keeping blood sugar levels low can help patients with advanced solid tumors that haven't responded to other treatments.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.