Metastatic Colorectal Cancer With Left-sided Primary TumorPhase 2NCT07070713
Efficacy and Safety of FOLFOX+Cetuximab vs. FOLFOXIRI+Bevacizumab Both With QL1706 in First-Line Treatment of Left-Sided mCRC
A Phase 2 study testing FOLFOXIRI + QL1706 + Bevacizumab and FOLFOX+QL1706+Cetuximab in people with Metastatic Colorectal Cancer With Left-sided Primary Tumor and Immunotherapy, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
This is a two-arm, randomized phase II clinical study. It is planned to enroll 44 patients with primary left-sided, RAS and BRAF wild-type metastatic colorectal cancer. After signing the informed consent, eligible subjects will be screened to enter the clinical study and assigned to two treatment groups using simple… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer With Left-sided Primary Tumor, Immunotherapy
- What is being tested?
- FOLFOXIRI + QL1706 + Bevacizumab and FOLFOX+QL1706+Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 30 Aug 2028
- Phase
- Phase 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
- Age 18 to 75 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma with the primary tumor located in the left-sided colon (from the splenic flexure to the rectum), including cecal adenocarcinoma.
- Presence of at least one evaluable lesion according to RECIST v1.1 criteria.
- The subject has provided sufficient tumor tissue samples through colonoscopy biopsy for MSI, TMB, and other tests.
- Tumors confirmed by tissue testing to be wild-type for KRAS, NRAS, and BRAF.
Show all 11Show fewer
- Within 7 days prior to the first dose of study drug, laboratory tests meet the following criteria (no blood products, hematopoietic growth factors, albumin, or other corrective treatments within 14 days prior to testing): (1) Biochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN), or ≤ 5 times ULN in the presence of liver metastases; total bilirubin (TBIL) ≤ 1.5 times ULN, or ≤ 2 times ULN in the presence of liver metastases; serum creatinine ≤ 1.5 times ULN, or creatinine clearance > 50 mL/min (calculated by the Cockcroft-Gault formula). (2) Hematology: Hemoglobin (Hb) ≥ 9.0 g/dL. No red blood cell transfusions within 1 week prior to the baseline Hb test; absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L. No platelet transfusions within 1 week prior to the baseline platelet test. (3) Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN (for subjects receiving prophylactic anticoagulation therapy without active bleeding [i.e., no bleeding within the past 14 days], the investigator should determine that the INR is within a safe and effective therapeutic range). (4) Urinalysis: Urine protein ≤ 30 mg/dL (1+) by dipstick or routine urinalysis (if ≥ 2+, then a 24-hour urine protein quantification must be < 1 g/24h).
- Estimated survival of at least 3 months.
- No contraindications to chemotherapy or immunotherapy.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use a reliable and effective method of contraception during the study and for 5 months after the last dose of study drug. Men whose partners are women of childbearing potential must agree to use a reliable and effective method of contraception during the study and for 5 months after the last dose of study drug. Lactating women are not eligible.
- The subject must provide informed consent for the study prior to enrollment, voluntarily sign a written informed consent form, and be willing and able to comply with the study visit schedule, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Confirmed by histopathological or cytological examination as other pathological types, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc. For mixed pathological types, the determination will be made based on the predominant component; adenocarcinoma component > 70% confirmed by pathologist is eligible for enrollment. Primary appendiceal tumors are exclusion criteria.
- Presence of other active malignancies within the past 3 years, except for early malignancies that have been cured (carcinoma in situ or stage I tumors), such as adequately treated cervical carcinoma in situ, thyroid cancer, basal cell or squamous cell carcinoma of the skin, etc.
- Previous systemic therapy for unresectable/metastatic colorectal cancer.
- Active autoimmune disease within the past 2 years requiring systemic treatment (i.e., immunomodulatory drugs, corticosteroids, or immunosuppressive agents); however, replacement therapy (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) will not be considered systemic treatment and is permitted.
- Presence of immunodeficiency or receipt of long-term systemic corticosteroid therapy (daily dose > 10 mg prednisone or equivalent corticosteroid) within 7 days prior to enrollment, or other immunosuppressive therapy.
- Uncontrolled diabetes mellitus; peripheral neuropathy ≥ Grade 2.
Show all 21Show fewer
- Active tuberculosis, or receipt of anti-tuberculosis treatment within 1 year prior to enrollment.
- If hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) are positive, the patient's HBV-DNA must be less than 500 IU/mL. For patients with active hepatitis B, the patient must have received antiviral therapy for at least 14 days prior to enrollment (according to local standard treatment, such as entecavir or tenofovir) and agree to continue effective antiviral therapy during the study.
- If HCV antibody is positive, HCV-RNA testing will be performed; if HCV-RNA > 1,000 copies/mL, the patient will be excluded.
- Receipt of any live vaccine within 28 days prior to enrollment (e.g., vaccines for infectious diseases, such as influenza vaccine, varicella vaccine, etc.).
- Previous allogeneic bone marrow transplant or solid organ transplant.
- Major surgery within 4 weeks prior to the first dose, or significant trauma, or presence of a wound that has not healed or healed poorly or complications in wound management.
- Known allergy to any component of the study drug; known multiple allergies or history of severe allergic diseases.
- Systemic anti-infective therapy within 2 weeks prior to the first dose.
- Receipt of nonsteroidal anti-inflammatory drugs, antiplatelet agents, or anticoagulants within 7 days prior to the first dose or ongoing.
- Active infectious diseases, such as HIV/AIDS or active syphilis.
- Use of any other investigational drug within 28 days prior to randomization or participation in another investigational drug trial.
- Clinically significant underlying medical conditions that may affect the administration of the study drug or compliance with the protocol, as judged by the investigator.
- Known history of psychiatric illness, drug abuse, alcoholism, or drug addiction.
- Pregnant or breastfeeding women.
- Other individuals deemed inappropriate for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fujian Cancer Hospital
Fuzhou, Fujian
Rongbo Lin, 13705919382, rongbo_lin@163.com
About this study
Official title: Assess and Compare the Efficacy and Safety of FOLFOX Combined With Cetuximab Versus FOLFOXIRI Combined With Bevacizumab When Both Used in Combination With QL1706 for First-line Treatment of Metastatic Colorectal Cancer With Left-sided Primary Tumors.
This is a two-arm, randomized phase II clinical study. It is planned to enroll 44 patients with primary left-sided, RAS and BRAF wild-type metastatic colorectal cancer. After signing the informed consent, eligible subjects will be screened to enter the clinical study and assigned to two treatment groups using simple randomization and allocation concealment methods.
The treatment plans for the two groups are as follows:
Read more
Group A: FOLFOXIRI (Irinotecan 165mg/m², iv, d1; Oxaliplatin 85mg/m², iv, d1; (Levo) Folinic Acid (200) 400mg/m², iv, d1; total 5-FU 2400mg/m², iv gtt (continuous for 48h), d1) + Bevacizumab (5mg/kg, i.v, Q2W) Group B: FOLFOX (Oxaliplatin 85mg/m², iv gtt (for 2h), d1; (Levo) Folinic Acid (200) 400mg/m², iv gtt (for 2h), d1; 5-FU 400mg/m², iv, followed by 2400mg/m², iv gtt (continuous for 46-48h), d1) + Cetuximab (500mg/m², i.v, Q2W) Both groups A and B will repeat the treatment every 2 weeks, for a maximum of 9 cycles. Then, the attending physician will decide whether to conduct maintenance treatment (Capecitabine or 5FU/LV with or without Bevacizumab is recommended).
Both groups A and B will be combined with QL1706 (5mg/kg, i.v, Q3W) for a maximum of 52 weeks.
Medication will continue until the researcher judges that there is no longer clinical benefit (the researcher makes a comprehensive judgment based on RECIST v1.1 imaging evaluation and clinical status, etc.), intolerable toxicity occurs, the subject withdraws informed consent, or other criteria for terminating treatment in the protocol are met, whichever comes first.
- Being tested
- FOLFOXIRI + QL1706 + Bevacizumab, FOLFOX+QL1706+Cetuximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRI + QL1706 + BevacizumabDrug
FOLFOXIRI(Irinotecan 165mg/m², iv, d1; Oxaliplatin 85mg/m², iv, d1; (Levo) Folinic Acid (200) 400mg/m², iv, d1; total 5-FU 2400mg/m², iv gtt (continuous for 48h), d1) + QL1706 (5mg/kg, i.v., Q3W) + Bevacizumab (5mg/kg, i.v., Q2W)
FOLFOX+QL1706+CetuximabDrug
FOLFOX (Oxaliplatin 85mg/m², iv gtt (for 2h), d1; (Levo) Folinic Acid (200) 400mg/m², iv gtt (for 2h), d1; 5-FU 400mg/m², iv, followed by 2400mg/m², iv gtt (continuous for 46-48h), d1) + QL1706 (5mg/kg, i.v., Q3W) + Cetuximab (500mg/m², i.v., Q2W).
| Study group | Role | What they receive |
|---|---|---|
| A group：FOLFOXIRI + QL1706 + Bevacizumab | Experimental | FOLFOXIRI (irinotecan 165 mg/m², iv, d1; oxaliplatin 85 mg/m², iv, d1; (levo)leucovorin 400 mg/m², iv, d1; 5-FU total dose 2400 mg/m², iv infusion (continuous for 48 hours), d1) +QL1706 (5mg/kg, i.v, Q3W) + bevacizumab (5 mg/kg, i.v., every 2 weeks). Receives: Drug: FOLFOXIRI + QL1706 + Bevacizumab |
| B group：FOLFOX + QL1706 + Cetuximab | Active comparator | FOLFOX (oxaliplatin 85 mg/m², intravenous infusion (2 hours), day 1; (levo)leucovorin (200) 400 mg/m², intravenous infusion (2 hours), day 1; 5-FU 400 mg/m², intravenous injection, followed by 2400 mg/m², intravenous infusion (continuous for 46-48 hours), day 1) +QL1706 (5mg/kg, i.v, Q3W) + cetuximab (500 mg/m², intravenous infusion, every 2 weeks). Receives: Drug: FOLFOX+QL1706+Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The percentage of participants in the analysis dataset who achieve a best overall response of Complete Response (CR) or Partial Response (PR) from the start of treatment until disease progression or withdrawal from the study.
Measured: 18 weeks
Secondary outcomes (5)
Duration of Response
The time from the first assessment of Complete Response (CR) or Partial Response (PR) until the first assessment of Progressive Disease (PD) or death from any cause.
Measured: 52 weeks
Disease Control Rate
The proportion of patients whose tumors have shrunk or remained stable for a certain period of time, including cases of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
Measured: 18 weeks
Progression Free Survival
The time from the day of enrollment until the first occurrence of disease progression (PD) or death due to any cause.
Measured: 52 weeks
Overall Survival
It refers to the time from the date of enrollment to the date of death due to any cause.
Measured: 52 weeks
Incidence of Adverse Events
fatigue, nausea/vomiting, abdominal pain and diarrhea, stomatitis, hepatic dysfunction, myelosuppression, etc.
Measured: 30 days after the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer With Left-sided Primary TumorStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070713
- Sponsor's protocol ID
- SYLT-031
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 17 Jul 2025
- 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess and Compare the Efficacy and Safety of FOLFOX Combined With Cetuximab Versus FOLFOXIRI Combined With Bevacizumab When Both Used in Combination With QL1706 for First-line Treatment of Metastatic Colorectal Cancer With Left-sided Primary Tumors.
- ClinicalTrials.gov ID
- NCT07070713
- Acronym / sponsor ID
- SYLT-031
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 17 Jul 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.
This is a two-arm, randomized phase II clinical study. It is planned to enroll 44 patients with primary left-sided, RAS and BRAF wild-type metastatic colorectal cancer. After signing the informed consent, eligible subjects will be screened to enter the clinical study and assigned to two treatment groups using simple randomization and allocation concealment methods.
The treatment plans for the two groups are as follows:
Group A: FOLFOXIRI (Irinotecan 165mg/m², iv, d1; Oxaliplatin 85mg/m², iv, d1; (Levo) Folinic Acid (200) 400mg/m², iv, d1; total 5-FU 2400mg/m², iv gtt (continuous for 48h), d1) + Bevacizumab (5mg/kg, i.v, Q2W) Group B: FOLFOX (Oxaliplatin 85mg/m², iv gtt (for 2h), d1; (Levo) Folinic Acid (200) 400mg/m², iv gtt (for 2h), d1; 5-FU 400mg/m², iv, followed by 2400mg/m², iv gtt (continuous for 46-48h), d1) + Cetuximab (500mg/m², i.v, Q2W) Both groups A and B will repeat the treatment every 2 weeks, for a maximum of 9 cycles. Then, the attending physician will decide whether to conduct maintenance treatment (Capecitabine or 5FU/LV with or without Bevacizumab is recommended).
Both groups A and B will be combined with QL1706 (5mg/kg, i.v, Q3W) for a maximum of 52 weeks.
Medication will continue until the researcher judges that there is no longer clinical benefit (the researcher makes a comprehensive judgment based on RECIST v1.1 imaging evaluation and clinical status, etc.), intolerable toxicity occurs, the subject withdraws informed consent, or other criteria for terminating treatment in the protocol are met, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group：FOLFOXIRI + QL1706 + Bevacizumab | Experimental | Drug: FOLFOXIRI + QL1706 + BevacizumabFOLFOXIRI (irinotecan 165 mg/m², iv, d1; oxaliplatin 85 mg/m², iv, d1; (levo)leucovorin 400 mg/m², iv, d1; 5-FU total dose 2400 mg/m², iv infusion (continuous for 48 hours), d1) +QL1706 (5mg/kg, i.v, Q3W) + bevacizumab (5 mg/kg, i.v., every 2 weeks). |
| B group：FOLFOX + QL1706 + Cetuximab | Active comparator | Drug: FOLFOX+QL1706+CetuximabFOLFOX (oxaliplatin 85 mg/m², intravenous infusion (2 hours), day 1; (levo)leucovorin (200) 400 mg/m², intravenous infusion (2 hours), day 1; 5-FU 400 mg/m², intravenous injection, followed by 2400 mg/m², intravenous infusion (continuous for 46-48 hours), day 1) +QL1706 (5mg/kg, i.v, Q3W) + cetuximab (500 mg/m², intravenous infusion, every 2 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 to 75 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma with the primary tumor located in the left-sided colon (from the splenic flexure to the rectum), including cecal adenocarcinoma.
- Presence of at least one evaluable lesion according to RECIST v1.1 criteria.
- The subject has provided sufficient tumor tissue samples through colonoscopy biopsy for MSI, TMB, and other tests.
Key exclusion criteria (21 listed)
- Confirmed by histopathological or cytological examination as other pathological types, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc. For mixed pathological types, the determination will be made based on the predominant component; adenocarcinoma component > 70% confirmed by pathologist is eligible for enrollment. Primary appendiceal tumors are exclusion criteria.
- Presence of other active malignancies within the past 3 years, except for early malignancies that have been cured (carcinoma in situ or stage I tumors), such as adequately treated cervical carcinoma in situ, thyroid cancer, basal cell or squamous cell carcinoma of the skin, etc.
- Previous systemic therapy for unresectable/metastatic colorectal cancer.
- Active autoimmune disease within the past 2 years requiring systemic treatment (i.e., immunomodulatory drugs, corticosteroids, or immunosuppressive agents); however, replacement therapy (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) will not be considered systemic treatment and is permitted.
- Presence of immunodeficiency or receipt of long-term systemic corticosteroid therapy (daily dose > 10 mg prednisone or equivalent corticosteroid) within 7 days prior to enrollment, or other immunosuppressive therapy.
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 |
|---|---|---|
| FOLFOXIRI + QL1706 + BevacizumabFOLFOXIRI(Irinotecan 165mg/m², iv, d1; Oxaliplatin 85mg/m², iv, d1; (Levo) Folinic Acid (200) 400mg/m², iv, d1; total 5-FU 2400mg/m², iv gtt (continuous for 48h), d1) + QL1706 (5mg/kg, i.v., Q3W) + Bevacizumab (5mg/kg, i.v., Q2W) | Drug | A group：FOLFOXIRI + QL1706 + Bevacizumab |
| FOLFOX+QL1706+CetuximabFOLFOX (Oxaliplatin 85mg/m², iv gtt (for 2h), d1; (Levo) Folinic Acid (200) 400mg/m², iv gtt (for 2h), d1; 5-FU 400mg/m², iv, followed by 2400mg/m², iv gtt (continuous for 46-48h), d1) + QL1706 (5mg/kg, i.v., Q3W) + Cetuximab (500mg/m², i.v., Q2W). | Drug | B group：FOLFOX + QL1706 + Cetuximab |
Primary outcome
Objective Response Rate
Time frame: 18 weeks
The percentage of participants in the analysis dataset who achieve a best overall response of Complete Response (CR) or Partial Response (PR) from the start of treatment until disease progression or withdrawal from the study.
5 secondary outcomes
Duration of Response
Time frame: 52 weeks
Disease Control Rate
Time frame: 18 weeks
Progression Free Survival
Time frame: 52 weeks
Overall Survival
Time frame: 52 weeks
Incidence of Adverse Events
Time frame: 30 days after the end of study
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 Jul 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOXIRI + QL1706 + Bevacizumab and FOLFOX+QL1706+Cetuximab in people with Metastatic Colorectal Cancer With Left-sided Primary Tumor and Immunotherapy, run by Fujian Cancer Hospital at 1 site in China.
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 11 inclusion and 21 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 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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?
Contact rongbo lin (13705919382, rongbo_lin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 18 weeks). 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 Jul 2025.