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Sintilimab in Combination With Chidamide in Newly Diagnosed ENKTCL

NCT04994210 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-14

No results posted yet for this study

Summary

ENKTL is a highly aggressive NHL with a higher incidence in Asia. L-asparaginase containing chemotherapy regimens are the standard first-line treatment with apparently toxicities. In 2020 ASH, the investigators reported Sintilimab(anti-PD-1 antibody) plus Chidamide(an oral subtype-selective HDACi) yielded effective antitumor activity, durable response in patients with relapsed or refractory ENKTL(SCENT trial. Abstracts 644). The investigators next conducted a exploratory study to investigated the safety and efficacy of Sintilimab plus Chidamide(SC) for patients with newly diagnosed ENKTL(SCENT-2 trial).

Conditions

  • Safety and Efficacy

Interventions

DRUG

Sintilimab

1. To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of newly diagnosed ENKTCL patients 2. To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of newly diagnosed ENKTCL patients. 3. Exploring biomarkers that may have predictive effects.

DRUG

Chidamide

1. To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of newly diagnosed ENKTCL patients 2. To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of newly diagnosed ENKTCL patients. 3. Exploring biomarkers that may have predictive effects.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2023-08-31
Completion
2025-08-31

Countries

  • China

Study Locations

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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 NCT04994210 on ClinicalTrials.gov