Software-guided immunotherapy for advanced solid tumors
Interventional Software IRSW-MIM Guided Immunotherapy for Advanced Solid Tumors: a Phase II Clinical Trial.
This study is testing a new AI software that suggests a mix of immunotherapy drugs for people with advanced solid tumors, like lung and liver cancers, to see if it helps them respond better to treatment while reducing side effects.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | ipilimumab, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06478108 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and effectiveness of an AI-based software, IRSW-MIM, which recommends a combination of immunotherapy drugs for patients with advanced solid tumors, including lung and liver cancers. The approach involves intra-tumor injections of multiple drugs, including CTLA4 and PD1 antibodies, along with other therapeutic agents delivered via interventional radiology techniques. The study aims to improve local drug concentration in tumors, enhance treatment efficacy, and minimize systemic side effects. Patients will be monitored for response rates and survival outcomes throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with confirmed advanced solid tumors and an estimated survival of over 3 months.
Not a fit: Patients with severe liver dysfunction or those who have participated in other clinical trials within the last 4 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced solid tumors.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific combination and AI-guided 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
- 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.