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Phase I/II Clinical Study of Decitabine Combined With TQB2450 Injection or Decitabine + Anlotinib Combined With TQB2450 Injection in the Treatment of PD-1 Monoclonal Antibody-resistant Digestive System Tumors

NCT04611711 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-11-02

No results posted yet for this study

Summary

This clinical study focused on patients with digestive system tumors resistant to PD-1 inhibitors, and explored the reversal resistance of epigenetic drugs (decitabine) and TKI drugs (anlotinib) in this part of patients.

Conditions

  • Patients With Digestive System Tumors Resistant to PD-1 Inhibitors

Interventions

DRUG

decitabine＋ TQB2450 injection

"Real low-dose epigenetics drugs (decitabine) can reverse the resistance of PD-1 inhibitors by re-regulating the immune microenvironment. TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors."

DRUG

decitabine＋ TQB2450 injection＋Anlotinib

"Real low-dose epigenetics drugs (decitabine) can reverse the resistance of PD-1 inhibitors by re-regulating the immune microenvironment. TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors. Anlotinib Hydrochloride is a multi-target receptor tyrosine kinase inhibitor with significant inhibitory activity against angiogenesis related kinases (VEGFR1/2/3, FGFR1/2/3, etc.) and other tumor cell proliferation-related kinases (PDGFR /, C-Kit, RET, etc.), which can play a dual role in anti-tumor angiogenesis and tumor growth inhibition. "

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2020-12-01
Completion
2020-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04611711 on ClinicalTrials.gov