Interventional Software for Multi-immunotherapy of Solid Tumors

Phase 2

Recruiting

• Conditions: Lung Cancer; Liver Cancer; Solid Tumor, Adult
• Interventions: Device: IRSW-MIM

• Registration Number: NCT06478108
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Brief Summary

This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by intra-tumor (IT) injection of multiple drugs including CTLA4, PD1, and/or PDL1 antibodies combined with drugs-eluting beads loaded with IL2, chemodrug, anti-angiogenesis drug, et. al that will be recommended by an AI-based medical software named IRSW-MIM developed by a cooperating company.

Detailed Description

Malignant solid tumors including lung and liver cancers are the most common malignancy worldwide, and their mortality rates are very high. China has a huge population base with about 4,000,000 new cancer cases each year. More than 60% of the solid tumors in China are diagnosed at mid-to-late stage and have lost the chance of surgery. Recently a lot of therapeutic strategies have been developed and applied to clinic including targeted therapy and immunotherapy, but the overall therapeutic efficiency is still low. It is very difficult to treat patients with recurrent/refractory/metastatic advanced solid cancers and more alternative therapies are urgently needed.

Antibodies against CTLA4, PD1 and PDL1 are representative drugs for the check-points inhibitory agents, and their clinical indications have been approved in various types of tumors, including advanced melanoma, non-small cell lung cancer, renal cell carcinoma, and classical Hodgkin's lymphoma and late recurrent head and neck squamous cell carcinoma patients, et al. Those drugs are regularly systemically administrated by vein infusion, however, local delivery of those drugs via interventional radiology technique including trans-artery or intra-tumor injection may increase the local drug concentration of the tumor, improve the efficacy, and reduce systemic adverse reactions. CTLA4 antibody ipilimumab has been widely effectively using to combine with PD1 or PDL1 antibody or other drugs, therefore, an AI-based medical software has been developed to help to determine the detailed combinations and dosages according to personalized medical condition such as sex, body weight, key organ functions, tumor types and their PDL1 level, status of MSI and TMB, previous treatment, et. al. This software, named interventional radiology appliable software for muti-immunothepy (IRSW-MIM), will be assessed by clinical applications on cancer patients.

This phase II clinical trial is to test the the safety, efficacy and survival benefit of the IRSW-MIM guided immunotherapy for advanced solid tumors, including PFS, ORR, DCT, and median survival time.

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-23
• Study First Submitted QC: 2024-06-23
• Last Update Submitted: 2024-06-23
• Study First Posted: 2024-06-27
• Last Update Posted: 2024-06-27
• Primary Completion: 2028-12-30
• Study Completion: 2033-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IRSW-MIM	IRSW-MIM	-

Primary Outcome Measures

Name	Time	Method
Duration of remission (DOR)	5 years	DOR will be defined as the duration of the cancer remission
Safety of the reccommended treatment generated by the medical device	5 years	Safety will be assessed by recording all types of advise effects upon and after the treatment.
Disease control rate	5 years	Disease control rate will be defined as objective response rate + steady disease rate.
Progression-free survival	5 years	Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.

Trial Locations

Locations (1)

Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China