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The Safety and Tolerability of PD-L1 Monoclonal Antibody Plus Lenalidomide in The Treatment of Colorectal Cancer

NCT04326296 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-05-15

No results posted yet for this study

Summary

This study proposed by increasing dosage and expand the "3 + 3" queue, main component is divided into two phases, phase 1 for dose escalation, according to preliminary data recommended doses starting dose of climbing, the purpose is to evaluate the safety of combination therapy, tolerance, and explore the maximum tolerated dose (MTD) and right dose recommended development stage;Phase 2 was the expansion phase. Patients were included in the expansion study according to the appropriate dose recommended in phase 1, to further evaluate the safety and tolerability of combination therapy, recommend appropriate dose for phase II clinical trial, and preliminarily explore the efficacy of combination therapy.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

PD-L1 Monoclonal Antibody Combined With Lenalidomide

PD-L1 monoclonal antibody was administered by intravenous drip every 3 weeks.Lenalidomide was administered orally, 25mg once a day on days 1-21 of each repeat cycle of 28 days.

Sponsors & Collaborators

  • LiNing

    lead OTHER_GOV

Principal Investigators

  • Ning Li, PhD · Henan Cancer Hospital

  • Suxia Luo, PhD · Henan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-05-30
Primary Completion
2022-09-30
Completion
2023-03-31

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 NCT04326296 on ClinicalTrials.gov