Interventional Software for Multi-immunotherapy of Solid Tumors

NCT06478108 | Recruiting Phase 2

• 1 other identifier: ZZ-IRSW-MIM-024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Liver Cancer; Solid Tumor, Adult

Keywords

Solid Tumor; Medical device; Software; Immunotherapy; Interventional radiology

Outcome Measures

Primary Outcomes (4)

• Safety of the reccommended treatment generated by the medical device

  Safety will be assessed by recording all types of advise effects upon and after the treatment.

  5 years

• Progression-free survival

  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.

  5 years

• Disease control rate

  Disease control rate will be defined as objective response rate + steady disease rate.

  5 years

• Duration of remission (DOR)

  DOR will be defined as the duration of the cancer remission

  5 years

Secondary Outcomes (1)

• Overall survival

  5 years

Study Arms (1)

IRSW-MIM

EXPERIMENTAL

Device: IRSW-MIM

Interventions

IRSW-MIM DEVICE

IRSW-MIM collects patient's data and outputs a therapeutical strategy for treating advanced solid tumors.

IRSW-MIM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytohistological confirmation is required for diagnosis of cancer.
• Signed informed consent before recruiting.
• Age above 18 years with estimated survival over 3 months.
• Child-Pugh class A or B/Child score \> 7; ECOG score \< 2
• Tolerable coagulation function or reversible coagulation disorders
• 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
• At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
• Birth control.
• Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

You may not qualify if:

• Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
• Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
• Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
• Patients accompanied with other tumors or past medical history of malignancy;
• Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
• 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).
• Allergic to contrast agent;
• Any agents which could affect the absorption or pharmacokinetics of the study drugs
• Other conditions that investigator decides not suitable for the trial.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead
• Immuno (Guangzhou) Biomedicine S&T Ltd: collaborator

Study Sites (1)

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Zhenfeng Zhang, MD, PhD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng Zhang, MD, PhD

CONTACT

+862039195966; zhangzhf@gzhmu.edu.cn

Bingjia He, MD

CONTACT

+862039195965; 464677938@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2033
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

CN (1)