Intra-tumor Injection of Drug-eluting Microspheres With Multiple Drugs

Study Overview
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Brief Summary
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To study the safety and clinical effect of injection of drug-eluting microspheres with multiple chemodrug and protein drugs into advanced solid tumors.

Detailed Description
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Drug-eluting microspheres such as DC-beads will be loaded with IL2, PD1/PDL1/CTLA4 antibody, or /and VEGF/VEGFR antibody with or without doxorubicin/idarubicin for various time and injected into tumors under CT guidance. Side effects and treatment efficacy after injection of drug-eluting microspheres into malignant tumors will be assessed according to RICEST1.1 standard.

Official Title
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Intra-tumor Injection of Drug-eluting Microspheres Loading With Chemodrug Plus Checkpoint Inhibitors and IL2 for Treatment of Advanced Solid Tumors

Conditions
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Hepatocellular Carcinoma, Solid Tumor, Adult

Intervention / Treatment
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* Drug: Injection of drug-eluting microspheres with multiple drugs into solid tumors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Solid advanced malignant tumors Age between18 and 99 years Life expectancy is greater than three months Exclusion Criteria: Benign tumor Life expectancy is less than three months Serious medical comorbidity Others

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Drug-eluting beads loaded with various drugs including IL2, kytruda, imfinzi, yevoy, bevacizumag, or/and ramucirumab, doxorubicin/idarubicin are injected into solid tumors under CT guidance according to appropriate treatment strategy, once per 3-6 weeks, and the safety and efficacy will be evaluated by guidelines.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: DC-Beads loading with Chemodrug/IL2/PD1/CTLA4 antibodies<br>Intra-tumor injection of above drugs for patients with previous treatment with PDL1 antibody and relapsed. | Drug: Injection of drug-eluting microspheres with multiple drugs into solid tumors<br>* Under the guidance of CT, puncture fine needle was used to inject drug-eluting microspheres loading with multiple drugs into the tumor<br>* Other names: Checkpoint inhibitor (CPI) such as Keytruda plus chemodrug;|
| Experimental: Group 2: DC-Beads loading with Chemodrug/IL2/PDL1/CTLA4 antibodies<br>Intra-tumor injection of above drugs for patients with previous treatment with PD1 antibody and relapsed. | Drug: Injection of drug-eluting microspheres with multiple drugs into solid tumors<br>* Under the guidance of CT, puncture fine needle was used to inject drug-eluting microspheres loading with multiple drugs into the tumor<br>* Other names: Checkpoint inhibitor (CPI) such as Keytruda plus chemodrug;|
| Experimental: Group 3: DC-Beads loading with Chemodrug/IL2/PD1/PDL1/CTLA4 antibodies<br>Intra-tumor injection of above drugs for patients with previous heavily treated with PD1/PDL1/CTLA4 antibodies and relapsed. | Drug: Injection of drug-eluting microspheres with multiple drugs into solid tumors<br>* Under the guidance of CT, puncture fine needle was used to inject drug-eluting microspheres loading with multiple drugs into the tumor<br>* Other names: Checkpoint inhibitor (CPI) such as Keytruda plus chemodrug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing safety and treatment efficacy on intra-tumor injection of DEB for advanced tumors | Assessing incidence of side effects and primary clinical response of the intra-tumor injection of DEB in advanced solid cancers, including CR, PR, SD, and PD. | up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugemalimab；Adebrelimab；Envafolimab；Cadonilimab；, Bevacizumab; Ramucirumab, Hepatocellular Carcinoma; Lung Cancer; Solid Tumors, Drug-eluting Beads, IL2; Kytruda; Opdivo; Imfinza; Atezolizumab; Ipilimumab;, Treprizolizumab; Tirelizumab; Carellizumab; Sintilimab;