Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors
Triplex CTLA4/PD1/PDL1 Checkpoint Inhibitors Combination Therapy for Advanced Solid Tumors
1 other identifier
interventional
100
1 country
1
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 (IV), artery (IA) or intra-tumor (IT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 lung-cancer
Started Nov 2021
Longer than P75 for phase_1 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 28, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2035
June 25, 2024
June 1, 2024
8 years
December 28, 2021
June 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Safety of 3 drugs combination treatment
Safety will be assessed by recording all types of advise effects upon and after the treatment.
5 years
Progression-free survival
Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
5 years
Disease control rate
Disease control rate will be defined as objective response rate + steady disease rate.
5 years
Duration of remission (DOR)
DOR will be defined as the duration of the cancer remission.
5 years
Secondary Outcomes (1)
Overall survival
5 years
Study Arms (1)
3 drugs
EXPERIMENTALThree antibodies combination against PD1, PDL1, and CTLA4.
Interventions
This study has 3 subgroups: 1. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 1-2mg/kg via vein, every 3 weeks. 2. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 1-2mg/kg via sustained (10min) micro-pump infusion via artery, every 3 weeks. 3. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 50-150mg via intra-tumor fine needle injection in 5 min, every 3 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhenfeng Zhang, MD, PHD
Second Affiliated Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2021
First Posted
January 11, 2022
Study Start
November 1, 2021
Primary Completion (Estimated)
October 30, 2029
Study Completion (Estimated)
October 30, 2035
Last Updated
June 25, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share