RecruitingPhase 2Phase 3NCT03755739

Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors

A Phase II/III Trial of Comparison of Benefit of Administration of Checkpoint Inhibitors Plus Chemodrug Via Artery or Fine Needle to Tumor Versus Vein for Immunotherapy of Advanced Solid Tumors


Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

200 participants

Start Date

Nov 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This trial was designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by trans-artery/intra-tumor infusion of PD1/PDL1 antibody and/or CTLA4 antibody ipilimumab plus chemotherapeutic drug and to compare their differences.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether delivering immunotherapy and chemotherapy drugs directly into the tumor (through an artery or into the tumor itself) rather than through a vein is more effective for treating advanced solid tumors. **You may be eligible if...** - You have a confirmed diagnosis of advanced cancer (any solid tumor type) - You are 18 years or older with an estimated life expectancy of more than 3 months - Your liver function is within an acceptable range (Child-Pugh A or B) - Your blood counts, kidney, and liver markers are within acceptable thresholds - You have at least one measurable tumor lesion **You may NOT be eligible if...** - You have blood clotting disorders that cannot be corrected - Your organ function is too impaired for the procedure - You are pregnant - You have severe allergies to contrast dye or study medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCheckpoint inhibitor (CPI) such as Pembrolizumab plus chemotherapy

vein, artery, or intra-tumor infusion of checkpoint inhibitor (CPI) such as Pembrolizumab and/or Ipilimumab, plus chemotherapy to destroy cancer cells and release tumor antigen for improving CPI therapeutic efficacy.


Locations(1)

The Second Affiliated Hospital of Guangzhou Medical University

Guanzhou, Guangdong, China

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NCT03755739


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