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QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC

Q

Qilu Pharmaceutical

Status and phase

Enrolling
Phase 2

Conditions

Colorectal Carcinoma

Treatments

Drug: Bevacizumab
Drug: Oxaliplatin injection
Drug: Capecitabine
Drug: QL1706

Study type

Interventional

Funder types

Industry

Identifiers

NCT05799820
QL1706-208

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

    1. 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.
    1. Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled).
    1. Has active autoimmune disease that has required systemic treatment in past 2 years.
    1. Significant cardiovascular disease.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

QL1706
Experimental group
Treatment:
Drug: QL1706
QL1706 in combination with bevacizumab and XELOX
Experimental group
Treatment:
Drug: Capecitabine
Drug: QL1706
Drug: Bevacizumab
Drug: Oxaliplatin injection

Trial contacts and locations

1

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Central trial contact

Jin Li, MD

Data sourced from clinicaltrials.gov

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