Colorectal Cancer Metastatic to LiverPhase 1/2NCT07863869
The QL1706 Combined With Chemotherapy and Either Cetuximab or Bevacizumab in Potentially Resectable Colorectal Cancer Patients With Liver Metastases
A Phase 1/2 study testing Arm A and Arm B in people with Colorectal Cancer Metastatic to Liver, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
The goal of this clinical trial is to learn if QL1706 (Iparomlimab/ Tuvonralimab)+ chemotherapy+ cetuximab/bevacizumab works to treat potentially resectable colorectal cancer patients with liver metastases in adults. It will also learn about the safety of this therapeutic regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Metastatic to Liver
- What is being tested?
- Arm A and Arm B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to 27 Nov 2029
- Phase
- Phase 1/2
- 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
- Has signed a written informed consent form and voluntarily participates in this study;
- Age: 18-75 years old, regardless of gender;
- Histologically or cytologically confirmed colorectal adenocarcinoma with liver metastases, initially unresectable but potentially resectable as assessed by a multidisciplinary team (MDT), without other definite extrahepatic distant metastases;
- No prior systemic treatment;
- Known RAS and BRAF status;
- No contraindications to liver surgery;
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- At least one measurable lesion according to RECIST 1.1;
- ECOG performance status: 0-1;
- Expected survival time > 12 weeks;
- Sufficient organ and bone marrow function.
Who cannot join
- Active autoimmune diseases requiring systemic treatment occurring within 2 years before enrollment.
- Previous receipt of immune checkpoint inhibitors, including: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc.
- Previous receipt of targeted drugs targeting epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), or their receptors (VEGFR), including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, anlotinib, etc.
- Definite extrahepatic distant metastatic lesions.
- Unresectable primary tumor.
- HIV infection, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation (except corneal transplantation).
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- Previous or concurrent other malignant tumors within 5 years;
- Accompanying pleural effusion, pericardial effusion, or ascites that is uncontrollable and requires drainage.
- Known active pulmonary tuberculosis, radiation pneumonitis, drug-induced pneumonia, or other diseases, symptoms, or signs causing severe impairment of lung function.
About this study
Official title: A Phase ⅠB/Ⅱ Study of QL1706 Combined With Chemotherapy and Either Cetuximab or Bevacizumab in Potentially Resectable Colorectal Cancer Patients With Liver Metastases
The goal of this clinical trial is to learn if QL1706 (Iparomlimab/ Tuvonralimab)+ chemotherapy+ cetuximab/bevacizumab works to treat potentially resectable colorectal cancer patients with liver metastases in adults. It will also learn about the safety of this therapeutic regimen. The main questions it aims to answer are: Does QL1706+ Chemotherapy+ Cetuximab/Bevacizumab improve the 18-month progression free survival (PFS) rate of participants?
The study plans to enroll 90-102 patients, who will be divided into 2 arms based on the primary tumor location and genetic status.
Read more
Arm A: Patients with primary tumors located in the left colorectum and RAS ( Rat Sarcoma Virus ) and BRAF ( V-raf Murine Sarcoma Viral Oncogene Homolog B ) wild-type.
Arm B: Patients with primary tumors located in the right colorectum and/or RAS or BRAF mutant
The study consists of two phases: phase Ib ( safety run-in phase ) and phase II.
- Conditions
- Colorectal Cancer Metastatic to Liver
- Being tested
- Arm A, Arm B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm ADrug
QL1706 3mg/kg, IV, D1, Q2W, for a maximum of 2 years.
mFOLFOX6 : Oxaliplatin 85 mg/m², IV, D1, Q2W, for a maximum of 12 cycles. LV 400mg/m², IV, D1, Q2W, for a maximum of 2 years. 5-FU 400mg/m², IV, D1; followed by a continuous intravenous infusion of 1200mg/(m²•d) for 2 days (total dose 2400mg/m², infusion duration 46-48 hours), Q2W, for a maximum of 2 years.
Cetuximab 500mg/m², IV, D1, Q2W, for a maximum of 2 years.
Arm BDrug
QL1706 3mg/kg, IV, D1, Q2W, for a maximum of 2 years
FOLFOXIRI :
Irinotecan 150mg/m², IV, D1, Q2W, for a maximum of 12 cycles Oxaliplatin 85mg/m², IV, D1, Q2W, for a maximum of 12 cycles LV 400mg/m², IV, D1, Q2W, for a maximum of 2 years 5-FU (total dose: 2400mg/m²) via continuous intravenous infusion for 48 hours, D1, Q2W, for a maximum of 2 years
Bevacizumab 5mg/kg, IV, D1, Q2W, for a maximum of 2 years
| Study group | Role | What they receive |
|---|---|---|
| Arm A ( QL1706 Combined with mFOLFOX6 and Cetuximab ) | Experimental | Participants with primary tumors located in the left colorectum and RAS and BRAF wild-type will receive QL1706 Combined with mFOLFOX6 and Cetuximab Receives: Drug: Arm A |
| Arm B ( QL1706 Combined with FOLFOXIRI and Bevacizumab ) | Experimental | Participants with primary tumors located in the right colorectum and/or RAS or BRAF mutant will receive QL1706 Combined with FOLFOXIRI and Bevacizumab Receives: Drug: Arm B |
What is being measured
The primary outcome is the main question the study is designed to answer.
18-month Progression-Free Survival (PFS) rate in phase II
18-month PFS rate is defined as the proportion of participants who are alive and progression free at 18 months from start of study treatment. Assessed according to RECIST v1.1 by investigator.
Measured: From enrollment to 18 months after enrollment
safety in phase Ib
Determine frequency and severity of adverse events as assessed by NCI-CTCAE v5.0
Measured: From enrollment to 18 months after enrollment
Secondary outcomes (7)
R0/R1 resection rate
Measured: From enrollment to 18 months after enrollment
Objective Response Rate (ORR)
Measured: From enrollment to 18 months after enrollment
Progression-Free Survival (PFS)
Measured: From enrollment to 18 months after enrollment
Time to Response (TTR)
Measured: From enrollment to 18 months after enrollment
Disease Control Rate (DCR)
Measured: From enrollment to 18 months after enrollment
18-Month/24-Month No Evidence of Disease (NED) Rate
Measured: From enrollment to 24 months after enrollment
Adverse Event
Measured: From enrollment to 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startSep 2026 (estimated)
- Primary completion27 May 2029 (estimated)
- Study completion27 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Metastatic to LiverStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863869
- Sponsor's protocol ID
- QL-CRC-QIBA-1002
- Status last verified
- Oct 2025
- First submitted
- 31 Mar 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase ⅠB/Ⅱ Study of QL1706 Combined With Chemotherapy and Either Cetuximab or Bevacizumab in Potentially Resectable Colorectal Cancer Patients With Liver Metastases
- ClinicalTrials.gov ID
- NCT07863869
- Acronym / sponsor ID
- QL-CRC-QIBA-1002
- Conditions
- Colorectal Cancer Metastatic to Liver
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 27 May 2029 (estimated)
- Study completion
- 27 Nov 2029 (estimated)
- First posted
- 7 Oct 2026 (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 goal of this clinical trial is to learn if QL1706 (Iparomlimab/ Tuvonralimab)+ chemotherapy+ cetuximab/bevacizumab works to treat potentially resectable colorectal cancer patients with liver metastases in adults. It will also learn about the safety of this therapeutic regimen. The main questions it aims to answer are: Does QL1706+ Chemotherapy+ Cetuximab/Bevacizumab improve the 18-month progression free survival (PFS) rate of participants?
The study plans to enroll 90-102 patients, who will be divided into 2 arms based on the primary tumor location and genetic status.
Arm A: Patients with primary tumors located in the left colorectum and RAS ( Rat Sarcoma Virus ) and BRAF ( V-raf Murine Sarcoma Viral Oncogene Homolog B ) wild-type.
Arm B: Patients with primary tumors located in the right colorectum and/or RAS or BRAF mutant
The study consists of two phases: phase Ib ( safety run-in phase ) and phase II.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A ( QL1706 Combined with mFOLFOX6 and Cetuximab ) | Experimental | Drug: Arm AParticipants with primary tumors located in the left colorectum and RAS and BRAF wild-type will receive QL1706 Combined with mFOLFOX6 and Cetuximab |
| Arm B ( QL1706 Combined with FOLFOXIRI and Bevacizumab ) | Experimental | Drug: Arm BParticipants with primary tumors located in the right colorectum and/or RAS or BRAF mutant will receive QL1706 Combined with FOLFOXIRI and Bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has signed a written informed consent form and voluntarily participates in this study;
- Age: 18-75 years old, regardless of gender;
- Histologically or cytologically confirmed colorectal adenocarcinoma with liver metastases, initially unresectable but potentially resectable as assessed by a multidisciplinary team (MDT), without other definite extrahepatic distant metastases;
- No prior systemic treatment;
- Known RAS and BRAF status;
Key exclusion criteria (9 listed)
- Active autoimmune diseases requiring systemic treatment occurring within 2 years before enrollment.
- Previous receipt of immune checkpoint inhibitors, including: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc.
- Previous receipt of targeted drugs targeting epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), or their receptors (VEGFR), including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, anlotinib, etc.
- Definite extrahepatic distant metastatic lesions.
- Unresectable primary tumor.
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 |
|---|---|---|
| Arm AQL1706 3mg/kg, IV, D1, Q2W, for a maximum of 2 years. mFOLFOX6 : Oxaliplatin 85 mg/m², IV, D1, Q2W, for a maximum of 12 cycles. LV 400mg/m², IV, D1, Q2W, for a maximum of 2 years. 5-FU 400mg/m², IV, D1; followed by a continuous intravenous infusion of 1200mg/(m²•d) for 2 days (total dose 2400mg/m², infusion duration 46-48 hours), Q2W, for a maximum of 2 years. Cetuximab 500mg/m², IV, D1, Q2W, for a maximum of 2 years. | Drug | Arm A ( QL1706 Combined with mFOLFOX6 and Cetuximab ) |
| Arm BQL1706 3mg/kg, IV, D1, Q2W, for a maximum of 2 years FOLFOXIRI : Irinotecan 150mg/m², IV, D1, Q2W, for a maximum of 12 cycles Oxaliplatin 85mg/m², IV, D1, Q2W, for a maximum of 12 cycles LV 400mg/m², IV, D1, Q2W, for a maximum of 2 years 5-FU (total dose: 2400mg/m²) via continuous intravenous infusion for 48 hours, D1, Q2W, for a maximum of 2 years Bevacizumab 5mg/kg, IV, D1, Q2W, for a maximum of 2 years | Drug | Arm B ( QL1706 Combined with FOLFOXIRI and Bevacizumab ) |
Primary outcome
18-month Progression-Free Survival (PFS) rate in phase II
Time frame: From enrollment to 18 months after enrollment
18-month PFS rate is defined as the proportion of participants who are alive and progression free at 18 months from start of study treatment. Assessed according to RECIST v1.1 by investigator.
safety in phase Ib
Time frame: From enrollment to 18 months after enrollment
Determine frequency and severity of adverse events as assessed by NCI-CTCAE v5.0
7 secondary outcomes
R0/R1 resection rate
Time frame: From enrollment to 18 months after enrollment
Objective Response Rate (ORR)
Time frame: From enrollment to 18 months after enrollment
Progression-Free Survival (PFS)
Time frame: From enrollment to 18 months after enrollment
Time to Response (TTR)
Time frame: From enrollment to 18 months after enrollment
Disease Control Rate (DCR)
Time frame: From enrollment to 18 months after enrollment
18-Month/24-Month No Evidence of Disease (NED) Rate
Time frame: From enrollment to 24 months after enrollment
Adverse Event
Time frame: From enrollment to 24 months after enrollment
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 19 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Arm A and Arm B in people with Colorectal Cancer Metastatic to Liver, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 10 inclusion and 9 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 19 Oct 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18-month Progression-Free Survival (PFS) rate in phase II (time frame: From enrollment to 18 months after enrollment). The study lists 2 primary outcomes in all. 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 19 Oct 2026.