Actively Recruiting
Clinical Efficacy of Tumour Treatment Vaccine (TTV) Combined With PD-1 in the Treatment of Relapsed Refractory Advanced Solid Tumours
Led by Wuxi People's Hospital · Updated on 2024-05-28
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical efficacy of the Tumour Treatment Vaccine (TTV) combined with PD-1/PD-L1 inhibitors in treating relapsed and refractory advanced solid tumors. Previous studies showed that TTV can enhance the anti-tumor effect of immune checkpoint inhibitor therapy, reaching a tumor suppression rate of 75.96% when combined with PD-1 inhibitors. This study aims to assess this combination treatment from a clinical perspective in patients with advanced solid tumors. The treatment involves administering the tumor treatment vaccine (TTV) by deep subcutaneous injection into the arm or near the tumor. PD-1/L1 inhibitors are used according to their approved indications. The initial TTV dose is 1 ml per injection, which may be increased to 2.5-4.0 ml depending on patient response. The timing between injections can be adjusted based on the patient's condition and reaction. This is an interventional study with an experimental group receiving the combined treatment. Participants will be monitored for tumor relief immediately after the last treatment. The study includes evaluations of measurable lesions using standard criteria and assessments of overall health and treatment response. Participants must comply with follow-up visits and provide informed consent. The study runs from May 2024 to December 2027 and includes safety monitoring and tumor response measurements throughout the treatment period.
CONDITIONS
Brief Title
Clinical Efficacy of Tumour Treatment Vaccine (TTV) Combined With PD-1 in the Treatment of Relapsed Refractory Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Histologically or cytologically confirmed advanced solid tumor(s) with progression or ineligibility for standard therapy
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 to 2 with expected lifespan greater than 12 weeks
- Negative pregnancy test for women of childbearing age within 7 days before treatment
- Use of contraceptive methods by women of childbearing age and male partners during treatment and for 6 months after last dose
- Willingness to participate voluntarily, sign informed consent, and comply with follow-up
You will not qualify if you...
- Diagnosis of central nervous system leukemia
- White blood cell count greater than or equal to 50 x 10^9/L or rapid disease progression preventing full treatment
- Uncontrollable fungal, bacterial, viral infections or need for isolation treatment
- Positive for HIV, HBV, or HCV
- Central nervous system diseases or autoimmune CNS lesions, including stroke, epilepsy, and dementia
- Recent myocardial infarction, cardiac procedures, active angina, or cardiovascular conditions within 12 months
- Use of anticoagulation or severe coagulopathy (APTT > 70)
- Systemic corticosteroid or immunosuppressive treatment within 2 weeks prior to study drug
- COVID-19 infection within 2 weeks prior to study drug
- Any serious uncontrolled disease or condition deemed unsuitable by the investigator
- Other conditions considered unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration depending on treatment response
Participants receive Tumor Treatment Vaccine combined with PD-1/L1 inhibitors. The vaccine is given by deep subcutaneous injection in the arm or near the tumor. The dose and interval between injections may vary based on participant condition and response.
Visits occur according to treatment schedule; frequency may vary per participant
Trial Site Locations
Total: 1 location
1
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214043
Actively Recruiting
Research Team
P
Peihua Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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