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NCT05187338RecruitingPhase 1/2

Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors

Triplex CTLA4/PD1/PDL1 Checkpoint Inhibitors Combination Therapy for Advanced Solid Tumors

Source: ClinicalTrials.gov · Last updated 25 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
100 (estimated)
First submitted
28 Dec 2021
Start date
1 Nov 2021
Primary completion date
30 Oct 2029
Lead sponsor
Second Affiliated Hospital of Guangzhou Medical University
NCT number
NCT05187338

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 100
  • From 1 Nov 2021 to the primary completion date, 30 Oct 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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.

Lab values

  • 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).

Other

  • Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The second Affiliated Hospital of Guangzhou Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.