Status:
RECRUITING
Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Lung Cancer
Liver Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by infusion of CTLA4, PD1 and PDL1 antibodies combination through venous (...
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 can...
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 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2035
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05187338
Start Date
November 1 2021
End Date
October 30 2035
Last Update
June 25 2024
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260