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Recruiting Phase 1/2

Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors

NCT05187338 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2021-11-01
Last updated
2024-06-25

Condition(s) studied

Lung CancerLiver CancerColorectal CancerPancreas CancerOvary CancerHead and Neck CancerBreast CancerGastric CancerCervical CancerEsophageal CancerSarcoma

Investigational drug(s) / intervention(s)

ipilimumab +pembrolizumab +durvalumabAll Ipilimumab trials (132) →All Pembrolizumab trials (624) →All Durvalumab trials (220) →

ipilimumab +pembrolizumab +durvalumab: 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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Cytohistological confirmation is required for diagnosis of cancer. 2. Signed informed consent before recruiting. 3. Age above 18 years with estimated survival over 3 months. 4. Child-Pugh class A or B/Child score \> 7; ECOG score \< 2 5. Tolerable coagulation function or reversible coagulation disorders 6. 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 7. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1. 8. Birth control. 9. Willing and able to comply with scheduled visits, treatment plan and laboratory tests. Exclusion Criteria: 1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks; 2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding; 3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders; 4. Patients accompanied with other tumors or past medical history of malignancy; 5. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment; 6. 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). 7. Allergic to contrast agent; 8. Any agents which could affect the absorption or pharmacokinetics of the study drugs 9. Other conditions that investigator decides not suitable for the trial.

Primary outcome measure(s)

  • Safety of 3 drugs combination treatment — 5 years
    Safety will be assessed by recording all types of advise effects upon and after the treatment.
  • Progression-free survival — 5 years
    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.
  • Disease control rate — 5 years
    Disease control rate will be defined as objective response rate + steady disease rate.
  • Duration of remission (DOR) — 5 years
    DOR will be defined as the duration of the cancer remission.

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05187338 on ClinicalTrials.gov ↗ ← All trials in China