Combination therapy using checkpoint inhibitors for advanced solid tumors
Triplex CTLA4/PD1/PDL1 Checkpoint Inhibitors Combination Therapy for Advanced Solid Tumors
This study is testing a new combination treatment using special antibodies for people with advanced solid tumors like lung and liver cancer to see if it can be safer and more effective than current options.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | ipilimumab, pembrolizumab, durvalumab, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05187338 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and effectiveness of a combination therapy using CTLA4, PD1, and PDL1 antibodies for patients with advanced solid tumors, including lung, liver, colorectal, pancreas, and ovary cancers. The treatment is administered through various methods, including intravenous, intra-arterial, or intra-tumor infusion, aiming to enhance local drug concentration and reduce systemic side effects. The study is particularly relevant given the high mortality rates associated with these cancers and the urgent need for alternative therapies in patients with recurrent or metastatic disease.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with confirmed diagnoses of advanced solid tumors and an estimated survival of over three months.
Not a fit: Patients with severe liver dysfunction, active bleeding, or those who have participated in other clinical trials within the last four weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve treatment outcomes and survival rates for patients with advanced solid tumors.
How similar studies have performed: While similar approaches using checkpoint inhibitors have shown promise in other studies, this specific combination and delivery method is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Zhenfeng Zhang, MD, PHD — Second Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Zhenfeng Zhang, MD, PHD
- Email: zhangzhf@gzhmu.edu.cn
- Phone: +862039195966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.