NCT05799820

Brief Summary

This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 29, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

May 25, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

March 23, 2023

Last Update Submit

May 23, 2023

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Up to approximately 2 years

Secondary Outcomes (4)

  • Disease Control Rate (DCR)

    Up to approximately 2 years

  • Duration of Response (DOR)

    Up to approximately 2 years

  • Progression-free Survival (PFS)

    Up to approximately 2 years

  • Overall Survival (OS)

    Up to approximately 2 years

Study Arms (2)

QL1706

EXPERIMENTAL
Drug: QL1706

QL1706 in combination with bevacizumab and XELOX

EXPERIMENTAL
Drug: QL1706Drug: BevacizumabDrug: Oxaliplatin injectionDrug: Capecitabine

Interventions

QL1706DRUG

5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

QL1706QL1706 in combination with bevacizumab and XELOX
BevacizumabDRUG

7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

QL1706 in combination with bevacizumab and XELOX
Oxaliplatin injectionDRUG

130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle

QL1706 in combination with bevacizumab and XELOX
CapecitabineDRUG

1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle

QL1706 in combination with bevacizumab and XELOX

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Subjects participate voluntarily and sign informed consent.
  • \. Age ≥ 18 and ≤ 80 years old, male or female.
  • \. Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum.
  • \. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).

You may not qualify if:

  • \. Diagnosed additional maliganancy within 5 years with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
  • \. Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled).
  • \. Has active autoimmune disease that has required systemic treatment in past 2 years.
  • \. Significant cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

BevacizumabOxaliplatinCapecitabine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Jin Li, MD

    Shanghai East Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Li, MD

CONTACT

+86 021-38804518lijin@csco.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 5, 2023

Study Start

September 29, 2022

Primary Completion

March 30, 2024

Study Completion

September 30, 2025

Last Updated

May 25, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)