Status:
RECRUITING
Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Hepatocarcinoma
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 an...
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 ca...
Eligibility Criteria
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;
- 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.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2036
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03755739
Start Date
November 1 2018
End Date
November 1 2036
Last Update
June 25 2024
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, China, 51260