Metastatic Colorectal CancerPhase 3NCT07025239
QL1706 Injection Plus Bevacizumab and XELOX vs Placebo Plus Bevacizumab and XELOX as First-Line Treatment of Unresectable Metastatic Colorectal Cancer
A Phase 3 study testing QL1706, Bevacizumab and Oxaliplatin in people with Metastatic Colorectal Cancer, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of QL1706 Injection in combination with bevacizumab and XELOX compared with placebo in combination with bevacizumab and XELOX for first-line treatment in patients with unresectable mCRC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- QL1706, Bevacizumab and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who voluntarily sign the informed consent form (ICF) and can understand and comply with the study requirements;
- Males and females aged 18 to 75 years old (including boundary value) on the date of signing ICF;
- Unresectable metastatic colorectal adenocarcinoma confirmed by histopathology examination;
- No previous systemic anti-tumor drug therapy for metastatic colorectal adenocarcinoma;
- At least one target lesion as judged by the investigator per RECIST v1.1 (lesions previously treated with topical treatment such as radiotherapy should not be considered as target lesions, unless it is confirmed that there has been definite progression of lesions located in the previous radiotherapy region);
- Be able to provide sufficient previously archived tumor tissue samples or agree to collect tumor tissue samples (≥ 5 unstained pathological tissue sections) by biopsy for biomarker testing. If sufficient tissue samples cannot be provided, it should be determined with the sponsor;
- ECOG PS score of 0 or 1 within 7 days before the first dose;
- Adequate liver, bone marrow, and renal organ function.
Who cannot join
- Patients had other active malignant tumors within 5 years prior to the first dose. Patients with localized tumors that have been cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of skin, superficial bladder carcinoma, carcinoma in situ of prostate, cervical carcinoma in situ, and breast carcinoma in situ, can be enrolled.
- Previous treatment with radiotherapy at any site within 4 weeks prior to the first dose.
- Previous treatment with postoperative adjuvant therapy with targeted drugs targeting epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF) or its receptor (VEGFR), including but not limited to Bevacizumab, Cetuximab, Panitumumab, Aflibercept, Regorafenib or Anlotinib;
- Previous treatment with any T cell costimulation or immune checkpoint inhibitors, including but not limited to anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-OX-40 or anti-CD137 monoclonal antibodies;
- Participation in a clinical study and treatment with study drug or device within 4 weeks prior to the first dose, or traditional Chinese medicine treatment < 2 weeks from the first dose;
- Patients who have a history of severe (≥ Grade 3) gastrointestinal ulcers, gastrointestinal perforation, fistula formation, intra-abdominal inflammation/abscess, intra-abdominal pneumatosis not due to puncture or surgery, macroscopic digestive tract hemorrhage/melena (excluding hemorrhoidal hemorrhage), and hemoptysis (about 3 mL or more) within 6 months prior to the first dose;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring drainage;
- Presence of dysphagia and unable to swallow the investigational product;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Multicenter Phase 3 Study of QL1706 Injection in Combination With Bevacizumab and XELOX Versus Placebo in Combination With Bevacizumab and XELOX as First-line Therapy for the Treatment of Patients With Unresectable Metastatic Colorectal Cancer (mCRC)
The purpose of this study is to evaluate the efficacy and safety of QL1706 Injection in combination with bevacizumab and XELOX compared with placebo in combination with bevacizumab and XELOX for first-line treatment in patients with unresectable mCRC.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- QL1706, Bevacizumab, Oxaliplatin, Capecitabine, Placebo
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Drug
QL1706 will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of QL1706 lasts for up to 2 years.
BevacizumabDrug
Bevacizumab will be administered by IV infusion at 7.5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Bevacizumab lasts for up to 2 years.
OxaliplatinDrug
Oxaliplatin will be administered by IV infusion at 130 mg/m2 on Day 1 of each 21-day cycle up to 8 treatment cycles.
CapecitabineDrug
Capecitabine will be administered orally at 1000 mg/m2 twice daily for 2 consecutive weeks, followed by one-week rest in each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Capecitabine lasts for up to 2 years.
PlaceboDrug
Placebo will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Placebo lasts for up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 + bevacizumab + XELOX | Experimental | Not described Receives: Drug: QL1706; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine |
| Placebo+ bevacizumab + XELOX | Placebo comparator | Not described Receives: Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) Assessed by the Independent Radiology Review Committee (IRRC)
PFS is defined as the time from randomization to the first documented progressive disease or deaths (whichever comes first), assessed per RECIST v1.1 criteria.
Measured: Up to approximately 2 years
Secondary outcomes (5)
Overall Survival (OS)
OS is defined as the time from the randomization to deaths, regardless of the cause of deaths
Measured: Approximately 66 months
Progression Free Survival (PFS) Assessed by Investigator
OS is defined as the time from the randomization to deaths, regardless of the cause of deaths
Measured: Up to approximately 2 years
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) per RECIST v1.1 criteria
Measured: Approximately 36 months
Duration Of Response (DOR)
ORR is defined as the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) per RECIST v1.1 criteria
Measured: Approximately 36 months
Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs).
Adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events are included. The investigator should carry out judgment for investigational drug correlation
Measured: From the subject signs the ICF to 30 days after the last dose of study drug is administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025239
- Sponsor's protocol ID
- QL1706-309
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Phase 3 Study of QL1706 Injection in Combination With Bevacizumab and XELOX Versus Placebo in Combination With Bevacizumab and XELOX as First-line Therapy for the Treatment of Patients With Unresectable Metastatic Colorectal Cancer (mCRC)
- ClinicalTrials.gov ID
- NCT07025239
- Acronym / sponsor ID
- QL1706-309
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of QL1706 Injection in combination with bevacizumab and XELOX compared with placebo in combination with bevacizumab and XELOX for first-line treatment in patients with unresectable mCRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1706 + bevacizumab + XELOX | Experimental | Drug: QL1706, Drug: Bevacizumab, Drug: Oxaliplatin, Drug: Capecitabine |
| Placebo+ bevacizumab + XELOX | Placebo comparator | Drug: Bevacizumab, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who voluntarily sign the informed consent form (ICF) and can understand and comply with the study requirements;
- Males and females aged 18 to 75 years old (including boundary value) on the date of signing ICF;
- Unresectable metastatic colorectal adenocarcinoma confirmed by histopathology examination;
- No previous systemic anti-tumor drug therapy for metastatic colorectal adenocarcinoma;
- At least one target lesion as judged by the investigator per RECIST v1.1 (lesions previously treated with topical treatment such as radiotherapy should not be considered as target lesions, unless it is confirmed that there has been definite progression of lesions located in the previous radiotherapy region);
Key exclusion criteria (8 listed)
- Patients had other active malignant tumors within 5 years prior to the first dose. Patients with localized tumors that have been cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of skin, superficial bladder carcinoma, carcinoma in situ of prostate, cervical carcinoma in situ, and breast carcinoma in situ, can be enrolled.
- Previous treatment with radiotherapy at any site within 4 weeks prior to the first dose.
- Previous treatment with postoperative adjuvant therapy with targeted drugs targeting epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF) or its receptor (VEGFR), including but not limited to Bevacizumab, Cetuximab, Panitumumab, Aflibercept, Regorafenib or Anlotinib;
- Previous treatment with any T cell costimulation or immune checkpoint inhibitors, including but not limited to anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-OX-40 or anti-CD137 monoclonal antibodies;
- Participation in a clinical study and treatment with study drug or device within 4 weeks prior to the first dose, or traditional Chinese medicine treatment < 2 weeks from the first dose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1706QL1706 will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of QL1706 lasts for up to 2 years. | Drug | QL1706 + bevacizumab + XELOX |
| BevacizumabBevacizumab will be administered by IV infusion at 7.5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Bevacizumab lasts for up to 2 years. | Drug | Placebo+ bevacizumab + XELOX, QL1706 + bevacizumab + XELOX |
| OxaliplatinOxaliplatin will be administered by IV infusion at 130 mg/m2 on Day 1 of each 21-day cycle up to 8 treatment cycles. | Drug | Placebo+ bevacizumab + XELOX, QL1706 + bevacizumab + XELOX |
| CapecitabineCapecitabine will be administered orally at 1000 mg/m2 twice daily for 2 consecutive weeks, followed by one-week rest in each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Capecitabine lasts for up to 2 years. | Drug | Placebo+ bevacizumab + XELOX, QL1706 + bevacizumab + XELOX |
| PlaceboPlacebo will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until disease progression (PD), intolerable toxicity, initiation of a new anti-tumor therapy, death, withdrawal of informed consent, loss to follow-up or other conditions requiring termination of the treatment (whichever occurs first). The administration of Placebo lasts for up to 2 years. | Drug | Placebo+ bevacizumab + XELOX |
Primary outcome
Progression Free Survival (PFS) Assessed by the Independent Radiology Review Committee (IRRC)
Time frame: Up to approximately 2 years
PFS is defined as the time from randomization to the first documented progressive disease or deaths (whichever comes first), assessed per RECIST v1.1 criteria.
5 secondary outcomes
Overall Survival (OS)
Time frame: Approximately 66 months
Progression Free Survival (PFS) Assessed by Investigator
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Approximately 36 months
Duration Of Response (DOR)
Time frame: Approximately 36 months
Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs).
Time frame: From the subject signs the ICF to 30 days after the last dose of study drug is administered
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QL1706, Bevacizumab and Oxaliplatin in people with Metastatic Colorectal Cancer, run by Qilu Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruihua Xu, PHD (020- 87343468, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) Assessed by the Independent Radiology Review Committee (IRRC) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.