NCT03478488

Brief Summary

This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer. The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
8mo left

Started Apr 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Apr 2018Dec 2026

First Submitted

Initial submission to the registry

March 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

6.4 years

First QC Date

March 21, 2018

Last Update Submit

May 27, 2025

Conditions

Biliary Tract Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    was defined as the time from randomization to death due to any cause.

    Observed by 12 weeks after progressive disease or end of treatment

Secondary Outcomes (5)

  • Progression Free Survival (PFS)

    Observed by 6 weeks

  • Objective response rate (ORR)

    Observed by 6 weeks

  • Disease control rate (DCR)

    Observed by 6 weeks

  • Duration of Response (DOR)

    Observed by 6 weeks

  • Time to progression (TTP)

    Observed by 6 weeks

Study Arms (2)

KN035

EXPERIMENTAL

KN035 plus Gemcitabine \& oxaliplatin KN035 2.5 mg/Kg, administered as subcutaneous injection, weekly of each 21-day cycle. Gemcitabine 1000 mg/m\^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m\^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles.

Drug: KN035 plus Gemcitabine & oxaliplatin

Gemcitabine & oxaliplatin

ACTIVE COMPARATOR

Gemcitabine 1000 mg/m\^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m\^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles.

Drug: Gemcitabine & oxaliplatin

Interventions

KN035 plus Gemcitabine & oxaliplatinDRUG

KN035 a programmed death ligand immune check inhibitor Per Investigator decision

Also known as: Experimental
KN035
Gemcitabine & oxaliplatinDRUG

The standard of care for the patients with unresectable/metastatic biliary tract cancer

Also known as: Active Comparator
Gemcitabine & oxaliplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eighteen years and older;
  • Histological or cytological diagnosis of unresectable or metastatic gallbladder cancer or cholangiocarcinoma;
  • Previously untreated with systemic therapy; Subjects who developed recurrent disease \>6 months after a sort of adjuvant, neoadjuvant chemotherapy could also be eligible.
  • Liver function Child-Pugh A or B;
  • Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
  • Life expectancy of at least 12 weeks;
  • At least one measurable lesion per RECIST 1.1;
  • Adequate organ function

You may not qualify if:

  • Specific anti-tumor treatment prior to 4 weeks;
  • more than 50% liver metastasis ;
  • Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection etc;
  • History of severe hypersensitivity reaction to any monoclonal antibody or chemistry;
  • Women who are pregnant or in the period of lactation;
  • Patients with an active, known or suspected autoimmune disease. Patients are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese people's liberation army (PLA) 81hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

envafolimabGemcitabineOxaliplatingemcitabine-oxaliplatin regimen

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Shukui Qin

    The Chinese people's liberation army (PLA) 81 hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2018

First Posted

March 27, 2018

Study Start

April 16, 2018

Primary Completion

September 10, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations

CN(1)