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KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

NCT05294172 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2026-05-08

No results posted yet for this study

Summary

The study is to evaluate the efficacy of KL-A167 combined with cisplatin and gemcitabine vs placebo combined with cisplatin and gemcitabine in the treatment of recurrent or metastatic nasopharyngeal carcinoma, as measured by progression-free survival (PFS) per the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

Conditions

  • Nasopharyngeal Carcinoma
  • Recurrent or Metastatic

Interventions

DRUG

KL-A167

KL-A167 4-6 cycles for combined therapy.KL-A167 maintenance.

DRUG

Gemcitabine

4-6 cycles for combined therapy

DRUG

Cisplatin

4-6 cycles for combined therapy.

DRUG

Placebo

4-6 cycles for combined therapy.Placebo maintenance.

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05294172 on ClinicalTrials.gov