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
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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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2022-09-29
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QL1706
QL1706
5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
QL1706 in combination with bevacizumab and XELOX
QL1706
5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Bevacizumab
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Oxaliplatin injection
130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Capecitabine
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
Bevacizumab
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Oxaliplatin injection
130mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Capecitabine
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Jin Li
Role: primary
Other Identifiers
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QL1706-208
Identifier Type: -
Identifier Source: org_study_id
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