Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Dec 28, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with advanced solid tumors, including various types of cancer like lung, liver, colorectal, and breast cancer. The study focuses on a combination of three immune-based therapies (CTLA4, PD1, and PDL1 antibodies) delivered through different methods, such as an IV (in your vein), IA (in your artery), or directly into the tumor. The main goals are to find out how safe this treatment is, how well it works, and how it affects survival rates for patients.

To be eligible for this trial, participants must be adults over 18 years old with a confirmed cancer diagnosis and an expected survival of at least three months. They should not have serious health issues that could complicate treatment and must agree to use birth control during the study. If you decide to participate, you can expect to have regular visits for treatment and tests, and you'll be closely monitored for any side effects. This trial is currently recruiting participants, and your involvement could help researchers learn more about effective treatments for advanced cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Cytohistological confirmation is required for diagnosis of cancer.
• • 2. Signed informed consent before recruiting.
• • 3. Age above 18 years with estimated survival over 3 months.
• • 4. Child-Pugh class A or B/Child score \> 7; ECOG score \< 2
• • 5. Tolerable coagulation function or reversible coagulation disorders
• • 6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L； PLT ≥50×10E9/L；INR \< 2.3 or PT \< 6 seconds above control；Cr ≤ 145.5 umul/L；Albumin \> 28 g/L；Total bilirubin \< 51 μmol/L
• • 7. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
• • 8. Birth control.
• • 9. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
• Exclusion Criteria:
• • 1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
• • 2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
• • 3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
• • 4. Patients accompanied with other tumors or past medical history of malignancy;
• • 5. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
• • 6. Patients have poor compliance.
• Any contraindications for hepatic arterial infusion procedure:
• • A.Impaired clotting test (platelet count \< 60000/mm3, prothrombin activity \< 50%).
• • B.Renal failure / insufficiency requiring hemo-or peritoneal dialysis. C.Known severe atheromatosis. D.Known uncontrolled blood hypertension (\> 160/100 mm/Hg).
• • 7. Allergic to contrast agent;
• • 8. Any agents which could affect the absorption or pharmacokinetics of the study drugs
• • 9. Other conditions that investigator decides not suitable for the trial.