Tests immunotherapy and chemotherapy given into arteries or tumors in advanced cancers
Tests checkpoint inhibitors plus chemotherapy in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors
Key facts
- Where
- Guanzhou, ChinaSee the site
- Phase
- Phase 2/3
Where in China
- The Second Affiliated Hospital of Guangzhou Medical UniversityGuanzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital of Guangzhou Medical University
- Trial code
- NCT03755739
- Record updated
- 25 June 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks; Any agents which could affect the absorption or pharmacokinetics of the study drugs; 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; Allergic to contrast agent; Other conditions that investigator decides not suitable for the trial; 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); Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment.