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

NCT ID: NCT05799820

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-29

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QL1706

Group Type EXPERIMENTAL

QL1706

Intervention Type DRUG

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

QL1706 in combination with bevacizumab and XELOX

Group Type EXPERIMENTAL

QL1706

Intervention Type DRUG

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

Bevacizumab

Intervention Type DRUG

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

Oxaliplatin injection

Intervention Type DRUG

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

Capecitabine

Intervention Type DRUG

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

Interventions

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QL1706

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

Intervention Type DRUG

Bevacizumab

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

Intervention Type DRUG

Oxaliplatin injection

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

Intervention Type DRUG

Capecitabine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Subjects participate voluntarily and sign informed consent.
* 2\. Age ≥ 18 and ≤ 80 years old, male or female.
* 3\. Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum.
* 4\. 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.
* 2\. Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled).
* 3\. Has active autoimmune disease that has required systemic treatment in past 2 years.
* 4\. Significant cardiovascular disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jin Li, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Locations

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Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jin Li, MD

Role: CONTACT

+86 021-38804518

Facility Contacts

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Jin Li

Role: primary

021-38804518

Other Identifiers

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QL1706-208

Identifier Type: -

Identifier Source: org_study_id

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