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The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer

NCT04183478 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2020-11-12

No results posted yet for this study

Summary

No Standard therapy has been approved for third-line therapy of advanced pancreatic cancer. K001 is peptidoglycan prepared from the marine microorganism, with an anti-tumor activity. Previously, the phase I study of K001 has shown that K001 was safety and had some effectiveness for pancreatic patients. Now, we would like to lunch a randomized, blinded, parallel-controlled, multi-center phase II/III study to compare the best support care (BSC) plus K-001 versus BSC plus placebo for the third-line and later treatment of patients with advanced pancreatic cancer.

Conditions

Interventions

DRUG

K-001

K-001 is an antitumor active substance (peptidoglycan) which is prepared from the fermentation product of marine microorganism. K-001 is the Chinese first class new drug and get patent licensing in China, America and Japan.

OTHER

placebo

Placebo which looks the same as K-001 in apparence

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Liwei Wang, Professor · Renji Hospital, School of Medicine, Shanghai Jiaotong University

  • Shukui Qin, Professor · Nanjing Bayi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04183478 on ClinicalTrials.gov