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RecruitingNCT05799820Updated May 25, 2023

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

A Phase 2 interventional study of QL1706 and Bevacizumab in Colorectal Carcinoma, sponsored by Qilu Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-25.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Sep 2022, registered Mar 2023).
  • Started Sep 2022; still recruiting 4 years later.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Carcinoma
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 60 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    QL1706

    Drug: QL1706

  • Experimental
    QL1706 in combination with bevacizumab and XELOX

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

Interventions

  • DrugQL1706

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

  • DrugBevacizumab

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

  • DrugOxaliplatin injection

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

  • DrugCapecitabine

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

06

What researchers measure

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).

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Disease Control Rate (DCR)

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

    Time frame: Up to approximately 2 years

  2. Duration of Response (DOR)

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

    Time frame: Up to approximately 2 years

  3. Progression-free Survival (PFS)

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

    Time frame: Up to approximately 2 years

  4. Overall Survival (OS)

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

    Time frame: Up to approximately 2 years

07

Study locations

1 of 1 sites recruiting
  • Shanghai East Hospital
    Shanghai, Shanghai 200120, China
    • Jin Li · Contact · 021-38804518
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05799820
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 5, 2023
Start date
Sep 29, 2022
Primary completion
Mar 30, 2024 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
May 25, 2023

Study contacts

Jin Li, MD
Contact
lijin@csco.org.cn
+86 021-38804518
Jin Li, MD
principal investigator · Shanghai East Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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