Colorectal NeoplasmsPhase 2conceptNCT07257653
The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line Treatment of RAS/BRAF Wild Type Unresectable Metastatic Colorectal Cancer
A Phase 2 study testing Cetuximab β；Fruquintinib；, Cetuximab β；Fruquintinib；anti-PD1 antibody； and Cetuximab β；Fruquintinib；anti-PD1/CTLA4 antibody in people with Colorectal Neoplasms and RAS, run by Zhejiang University at 1 site in China.
Trial summary
Colorectal cancer is a malignant tumor ranking among the top four in incidence and the top three in causes of death globally . Chemotherapy combined with anti-EGFR or anti-VEGF monoclonal antibodies is currently the standard first-line treatment for advanced pMMR colorectal cancer. Read more about this study
- Who is it for?
- Ages 10 to 85 years
- Conditions the study is for
- Colorectal Neoplasms, RAS, BRAF
- What is being tested?
- Cetuximab β；Fruquintinib；, Cetuximab β；Fruquintinib；anti-PD1 antibody； and Cetuximab β；Fruquintinib；anti-PD1/CTLA4 antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2025to 31 Dec 2027
- 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 10 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1）Subjects voluntarily join this study, sign the informed consent form, and demonstrate good compliance; 2) Age: 10-80 years old, ECOG PS score of 0-1. For patients aged 80-85, comprehensive functional assessments must be completed, and they may be enrolled if the investigator deems them tolerable, with an expected survival of over 3 months; 3) Histopathologically and/or cytologically confirmed, unresectable metastatic colorectal adenocarcinoma confirmed by MDT discussion (UICC/AJCC TNM staging system for colorectal cancer, 8th Edition, 2017); 4) At least one measurable lesion confirmed according to RECIST 1.1 criteria; 5) Adequate function of major organs, meeting the following criteria:
- Hematological examination standards (no blood transfusion or use of hematopoietic growth factors for correction within 7 days prior to screening):
- Hemoglobin (HGB) ≥ 90 g/L;
- Absolute neutrophil count (NEUT) ≥ 1.5 × 10⁹/L;
- Platelet count (PLT) ≥ 75 × 10⁹/L;
- Biochemical tests must meet the following criteria:
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- Total bilirubin (TBIL) ≤ 1.5 × ULN (≤ 3 × ULN for subjects with Gilbert's syndrome);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. If with liver metastases, ALT and AST ≤ 5 × ULN;
- Serum creatinine (CR) ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 50 ml/min.
- Coagulation function or thyroid function tests must meet the following criteria:
- Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5 × ULN (without anticoagulant therapy);
- Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be assessed (FT3 and FT4 may be substituted if T3/T4 are unavailable at the center). Subjects may be enrolled if T3 and T4 levels are normal.
- Echocardiogram assessment: Left ventricular ejection fraction (LVEF) ≥ 50%.
- Hepatitis B surface antigen (HBsAg) negative. If HBsAg positive, hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be < 2500 copies/mL or 500 IU/mL for enrollment.
- HCV antibody negative or HCV-RNA negative subjects may enroll; if HCV-RNA positive, subjects must have alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN to enroll. Subjects with co-infection of hepatitis B and hepatitis C are excluded (positive for HBsAg or HBcAb, and positive for HCV antibody).
- Female patients must meet one of the following conditions:
- Postmenopausal (defined as no menses for at least 1 year, with no other confirmed causes besides menopause), or
- Surgically sterilized (removal of ovaries and/or uterus), or
- Of childbearing potential but must meet the following:
- Serum/urine pregnancy test within 7 days prior to enrollment must be negative;
- Agree to use contraception with a failure rate of < 1% per year or maintain abstinence (avoiding heterosexual intercourse) (from signing the ICF until at least 6 months after the last dose of the study drug) (contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, copper intrauterine devices, or condoms);
- Must not be breastfeeding.
- Male patients must meet the following: Agree to abstinence (avoiding heterosexual intercourse) or use contraception, as specified: When the partner is a woman of childbearing potential or is pregnant, the male patient must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose to prevent fetal drug exposure. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Who cannot join
- Presence of MSI-H/dMMR patients.
- Concurrent diseases and medical history:
- Diagnosis of or concurrent other malignancies within the past 3 years. The following conditions are eligible for enrollment:
- Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)];
- Multiple factors affecting oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- History or tendency of gastrointestinal bleeding or perforation within 4 weeks prior to enrollment;
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- Patients with active inflammatory bowel disease within 4 weeks prior to enrollment;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Unresolved toxicities from any prior antitumor therapy exceeding CTCAE Grade 1 (excluding alopecia and oxaliplatin-induced neurotoxicity ≤ Grade 2);
- Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment (excluding gastrointestinal endoscopic biopsy);
- Symptoms of active bleeding within 1 week prior to screening, without significant improvement or control;
- Patients with any bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to study initiation, or presence of unhealed wounds, ulcers, or fractures;
- Arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- History of psychoactive drug abuse with inability to abstain;
- Patients with any severe and/or uncontrolled diseases, including:
- Uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after standard antihypertensive therapy);
- Myocardial ischemia ≥ Grade 2, myocardial infarction, arrhythmias (including QTc ≥450 ms for males, QTc ≥470 ms for females), and congestive heart failure ≥ Grade 2 (New York Heart Association (NYHA) classification);
- Active or uncontrolled severe infections (≥ CTCAE Grade 2 infection);
- Liver cirrhosis, active hepatitis*; (*Active hepatitis [Hepatitis B reference: HBsAg positive and HBV DNA positive (>2500 copies/mL or >500 IU/mL); Hepatitis C reference: HCV antibody positive and HCV viral titer above the upper limit of normal]. Note: Eligible HBsAg-positive or HBcAb-positive subjects and hepatitis C patients require continuous antiviral therapy to prevent viral reactivation.)
- Renal failure requiring hemodialysis or peritoneal dialysis;
- History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
- Poorly controlled diabetes (fasting blood glucose >10 mmol/L);
- Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein quantification >1.0 g;
- History of clear neurological or psychiatric disorders, including epilepsy or dementia requiring treatment.
- Patients with known active or suspected autoimmune diseases. Patients with immune-related hypothyroidism requiring thyroid hormone replacement therapy and well-controlled type I diabetes are allowed. Patients with vitiligo requiring no intervention or resolved childhood asthma/allergies requiring no intervention in adulthood are allowed.
- Receipt of live vaccines within 28 days prior to enrollment. However, inactivated viral vaccines for seasonal influenza are permitted, while live attenuated influenza vaccines administered intranasally are not allowed.
- Patients requiring systemic glucocorticoids (>10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days prior to enrollment or during the study. The following conditions are allowed for enrollment:
- Use of topical or inhaled glucocorticoids in the absence of active autoimmune diseases;
- Adrenal glucocorticoid replacement therapy at doses ≤10 mg/day prednisone equivalent.
- Participation in other clinical studies or initiation of study treatment within 14 days after the end of prior clinical study treatment. History of severe allergy to any monoclonal antibody.
- Tumor-related symptoms and treatment:
- Surgery (excluding prior diagnostic biopsies), radiotherapy, chemotherapy, or other anticancer therapies within 4 weeks prior to the start of study treatment (calculated from the end date of the last treatment as the washout period);
- Prior postoperative adjuvant therapy containing anti-angiogenic targeted drugs (including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, etc.);
- Patients with symptomatic brain metastases or those whose symptoms have been controlled for less than 2 months;
- Patients deemed by the investigator to have concomitant diseases that seriously endanger subject safety or affect study completion, or who are otherwise considered unsuitable for enrollment.
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, 1 recruiting
- Recruiting
Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, Zhejiang Province 310999
Hangzhou, Zhejiang
Ke-Feng Ding, phD, 86-571-87784827, dingkefeng@zju.edu.cn
About this study
Colorectal cancer is a malignant tumor ranking among the top four in incidence and the top three in causes of death globally . Chemotherapy combined with anti-EGFR or anti-VEGF monoclonal antibodies is currently the standard first-line treatment for advanced pMMR colorectal cancer. The inclusion of anti-EGFR or anti-VEGF targeted therapies has improved the overall survival of advanced colorectal cancer patients from 13 months in the era of fluorouracil monotherapy to the current 30 months.
However, many patients refuse chemotherapy or cannot tolerate cytotoxic chemotherapeutic drugs, which often leads to poor prognosis in advanced colorectal cancer. Thus, in the treatment of advanced colorectal cancer, is it possible to achieve antitumor activity through the combination of targeted drugs while avoiding chemotherapy?
Read more
Early clinical studies evaluated the possibility of combining anti-EGFR and anti-VEGF monoclonal antibodies. Subsequent large-scale Phase III clinical studies, such as PACCE , indicated that the combination of FOLFOX or FOLFIRI regimens with bevacizumab and panitumumab increased adverse reactions without providing survival benefits in the overall colorectal cancer population compared to the control group. Following this, the CAIRO2 clinical study added cetuximab to CapeOX combined with bevacizumab and still did not demonstrate survival benefits in the first-line treatment of advanced colorectal cancer, particularly in patients with RAS mutations. However, subgroup analyses suggested a certain survival advantage in patients with wild-type RAS who received combined targeted therapy. A recent clinical study (ECOG-ACRIN E7208) showed that in patients with KRAS wild-type advanced colorectal cancer, second-line use of irinotecan combined with cetuximab and ramucirumab significantly improved progression-free survival (PFS) and disease control rate (DCR) compared to cetuximab combined with irinotecan. These studies suggest that combining anti-EGFR and anti-VEGF monoclonal antibodies is a feasible approach for patients with wild-type RAS
Certainly, in terms of anti-VEGF options, besides macromolecular anti-VEGFR monoclonal antibodies, small-molecule tyrosine kinase inhibitors targeting VEGF have also demonstrated significant antitumor activity in colorectal cancer. Studies have shown that fruquintinib significantly prolongs the survival of patients with advanced colorectal cancer, leading to its approval as a third-line treatment for colorectal cancer.
On the other hand, immunotherapy targeting PD-1 and CTLA-4 has recently made significant progress in the treatment of colorectal cancer. For the pMMR type, which accounts for over 90% of advanced colorectal cancer cases, related clinical studies have confirmed that the combination of immunotherapy and targeted therapy has significant antitumor synergistic effects. These studies also indicate that immune checkpoint inhibitors can enhance the antitumor activity of anti-EGFR and anti-VEGF targeted therapies in pMMR advanced colorectal cancer.
This study aims to evaluate the efficacy and safety of cetuximab combined with fruquintinib, with or without immune checkpoint inhibitors, as a first-line treatment for pMMR, RAS/BRAF wild-type metastatic colorectal cancer.
Read the detailed description
According to the study design, 90 patients aged 18 to 80 years, with an ECOG score of 0-1, histologically confirmed colorectal adenocarcinoma, pMMR, KRAS/NRAS/BRAF wild-type, and unresectable metastases, including at least one measurable lesion as per RECIST 1.1 criteria, will be randomly assigned to three groups. They will receive the following treatments:
Arm A: Cetuximab β + Fruquintinib Arm B: Cetuximab β + Fruquintinib + anti-PD1 antibody Arm C: Cetuximab β + Fruquintinib + anti-PD1/CTLA4 antibody The primary endpoint is progression-free survival (PFS), and secondary endpoints include safety, ORR, and DCR.
- Conditions
- Colorectal Neoplasms, RAS, BRAF, Cetuximabβ, Fruquintinib
- Being tested
- Cetuximab β；Fruquintinib；, Cetuximab β；Fruquintinib；anti-PD1 antibody；, Cetuximab β；Fruquintinib；anti-PD1/CTLA4 antibody
- Keywords
- Colorectal cancer, Chemotherapy-free, KRAS/NRAS/BRAF wild-type, cetuximab combined with fruquintinib, with or without immune checkpoint inhibitors
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab β；Fruquintinib；Drug
Arm A：Cetuximab β（500mg/m2,iv,d1,q2w）+Fruquintinib(5mg, po, qd, 2w/1w)；
Cetuximab β；Fruquintinib；anti-PD1 antibody；Drug
Arm B：Cetuximab β (500mg/m2,iv,d1,q2w）+Fruquintinib（5mg, po, qd, 2w/1w）+Sintilimab（200mg, iv, d1, q3w）；
Cetuximab β；Fruquintinib；anti-PD1/CTLA4 antibodyDrug
Arm C：Cetuximab β(500mg/m2,iv,d1,q2w）+Fruquintinib（5mg, po, qd, 2w/1w）+anti-PD1/CTLA4 antibody(5mg/kg, d1, q3w)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Cetuximab β + Fruquintinib Receives: Drug: Cetuximab β；Fruquintinib； |
| Arm B | Experimental | Cetuximab β + Fruquintinib + anti-PD1 antibody Receives: Drug: Cetuximab β；Fruquintinib；anti-PD1 antibody； |
| Arm C | Experimental | Cetuximab β + Fruquintinib + anti-PD1/CTLA4 antibody Receives: Drug: Cetuximab β；Fruquintinib；anti-PD1/CTLA4 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS refers to the time from randomization (or the start of treatment) until the first observation of disease progression or death from any cause. The analysis is based on the full analysis set and the per-protocol set. The median PFS and its 95% CI were estimated using the Kaplan-Meier method, and survival curves were plotted.
Measured: 1 year
Secondary outcomes (4)
OS
OS refers to the time from randomization until death from any cause. The analysis is based on the full analysis set and the per-protocol set. The median OS and its 95% CI were estimated using the Kaplan-Meier method, and survival curves were plotted.
Measured: 2 years
ORR
ORR：The proportion of patients in a study who have achieved a predefined reduction in tumor burden for a minimum period of time. This includes patients with either a Complete Response (CR) or a Partial Response (PR)
Measured: 1 year
DCR
DCR：The proportion of patients in a study who have achieved Objective Response (CR or PR) or Stable Disease (SD) for a minimum specified duration.
Measured: 1 year
DOR
DOR：The time from when Objective Response (CR or PR) is first documented to the time of disease progression or death from any cause, whichever occurs first. This metric is calculated only for patients who have achieved an objective response.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start21 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Model description
- Arm A: Cetuximab β + Fruquintinib Arm B: Cetuximab β + Fruquintinib + anti-PD1 antibody Arm C: Cetuximab β + Fruquintinib + anti-PD1/CTLA4 antibody
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ke-Feng, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Kefeng Ding, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257653
- Sponsor's protocol ID
- concept
- Acronym
- concept
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line Treatment of RAS/BRAF Wild Type Unresectable Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07257653
- Acronym / sponsor ID
- concept / concept
- Conditions
- Colorectal Neoplasms, RAS, BRAF, Cetuximabβ, Fruquintinib
- Keywords
- Colorectal cancer, Chemotherapy-free, KRAS/NRAS/BRAF wild-type, cetuximab combined with fruquintinib, with or without immune checkpoint inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Dec 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.
Colorectal cancer is a malignant tumor ranking among the top four in incidence and the top three in causes of death globally . Chemotherapy combined with anti-EGFR or anti-VEGF monoclonal antibodies is currently the standard first-line treatment for advanced pMMR colorectal cancer. The inclusion of anti-EGFR or anti-VEGF targeted therapies has improved the overall survival of advanced colorectal cancer patients from 13 months in the era of fluorouracil monotherapy to the current 30 months.
However, many patients refuse chemotherapy or cannot tolerate cytotoxic chemotherapeutic drugs, which often leads to poor prognosis in advanced colorectal cancer. Thus, in the treatment of advanced colorectal cancer, is it possible to achieve antitumor activity through the combination of targeted drugs while avoiding chemotherapy?
Early clinical studies evaluated the possibility of combining anti-EGFR and anti-VEGF monoclonal antibodies. Subsequent large-scale Phase III clinical studies, such as PACCE , indicated that the combination of FOLFOX or FOLFIRI regimens with bevacizumab and panitumumab increased adverse reactions without providing survival benefits in the overall colorectal cancer population compared to the control group. Following this, the CAIRO2 clinical study added cetuximab to CapeOX combined with bevacizumab and still did not demonstrate survival benefits in the first-line treatment of advanced colorectal cancer, particularly in patients with RAS mutations. However, subgroup analyses suggested a certain survival advantage in patients with wild-type RAS who received combined targeted therapy. A recent clinical study (ECOG-ACRIN E7208) showed that in patients with KRAS wild-type advanced colorectal cancer, second-line use of irinotecan combined with cetuximab and ramucirumab significantly improved progression-free survival (PFS) and disease control rate (DCR) compared to cetuximab combined with irinotecan. These studies suggest that combining anti-EGFR and anti-VEGF monoclonal antibodies is a feasible approach for patients with wild-type RAS
Certainly, in terms of anti-VEGF options, besides macromolecular anti-VEGFR monoclonal antibodies, small-molecule tyrosine kinase inhibitors targeting VEGF have also demonstrated significant antitumor activity in colorectal cancer. Studies have shown that fruquintinib significantly prolongs the survival of patients with advanced colorectal cancer, leading to its approval as a third-line treatment for colorectal cancer.
On the other hand, immunotherapy targeting PD-1 and CTLA-4 has recently made significant progress in the treatment of colorectal cancer. For the pMMR type, which accounts for over 90% of advanced colorectal cancer cases, related clinical studies have confirmed that the combination of immunotherapy and targeted therapy has significant antitumor synergistic effects. These studies also indicate that immune checkpoint inhibitors can enhance the antitumor activity of anti-EGFR and anti-VEGF targeted therapies in pMMR advanced colorectal cancer.
This study aims to evaluate the efficacy and safety of cetuximab combined with fruquintinib, with or without immune checkpoint inhibitors, as a first-line treatment for pMMR, RAS/BRAF wild-type metastatic colorectal cancer.
Detailed description
According to the study design, 90 patients aged 18 to 80 years, with an ECOG score of 0-1, histologically confirmed colorectal adenocarcinoma, pMMR, KRAS/NRAS/BRAF wild-type, and unresectable metastases, including at least one measurable lesion as per RECIST 1.1 criteria, will be randomly assigned to three groups. They will receive the following treatments:
Arm A: Cetuximab β + Fruquintinib Arm B: Cetuximab β + Fruquintinib + anti-PD1 antibody Arm C: Cetuximab β + Fruquintinib + anti-PD1/CTLA4 antibody The primary endpoint is progression-free survival (PFS), and secondary endpoints include safety, ORR, and DCR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Arm A: Cetuximab β + Fruquintinib Arm B: Cetuximab β + Fruquintinib + anti-PD1 antibody Arm C: Cetuximab β + Fruquintinib + anti-PD1/CTLA4 antibody
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Cetuximab β；Fruquintinib；Cetuximab β + Fruquintinib |
| Arm B | Experimental | Drug: Cetuximab β；Fruquintinib；anti-PD1 antibody；Cetuximab β + Fruquintinib + anti-PD1 antibody |
| Arm C | Experimental | Drug: Cetuximab β；Fruquintinib；anti-PD1/CTLA4 antibodyCetuximab β + Fruquintinib + anti-PD1/CTLA4 antibody |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- 1）Subjects voluntarily join this study, sign the informed consent form, and demonstrate good compliance; 2) Age: 10-80 years old, ECOG PS score of 0-1. For patients aged 80-85, comprehensive functional assessments must be completed, and they may be enrolled if the investigator deems them tolerable, with an expected survival of over 3 months; 3) Histopathologically and/or cytologically confirmed, unresectable metastatic colorectal adenocarcinoma confirmed by MDT discussion (UICC/AJCC TNM staging system for colorectal cancer, 8th Edition, 2017); 4) At least one measurable lesion confirmed according to RECIST 1.1 criteria; 5) Adequate function of major organs, meeting the following criteria:
- Hematological examination standards (no blood transfusion or use of hematopoietic growth factors for correction within 7 days prior to screening):
- Biochemical tests must meet the following criteria:
- Coagulation function or thyroid function tests must meet the following criteria:
- Echocardiogram assessment: Left ventricular ejection fraction (LVEF) ≥ 50%.
Key exclusion criteria (35 listed)
- Presence of MSI-H/dMMR patients.
- Concurrent diseases and medical history:
- Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)];
- Tumor-related symptoms and treatment:
- Patients deemed by the investigator to have concomitant diseases that seriously endanger subject safety or affect study completion, or who are otherwise considered unsuitable for enrollment.
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 |
|---|---|---|
| Cetuximab β；Fruquintinib；Arm A：Cetuximab β（500mg/m2,iv,d1,q2w）+Fruquintinib(5mg, po, qd, 2w/1w)； | Drug | Arm A |
| Cetuximab β；Fruquintinib；anti-PD1 antibody；Arm B：Cetuximab β (500mg/m2,iv,d1,q2w）+Fruquintinib（5mg, po, qd, 2w/1w）+Sintilimab（200mg, iv, d1, q3w）； | Drug | Arm B |
| Cetuximab β；Fruquintinib；anti-PD1/CTLA4 antibodyArm C：Cetuximab β(500mg/m2,iv,d1,q2w）+Fruquintinib（5mg, po, qd, 2w/1w）+anti-PD1/CTLA4 antibody(5mg/kg, d1, q3w) | Drug | Arm C |
Primary outcome
PFS
Time frame: 1 year
PFS refers to the time from randomization (or the start of treatment) until the first observation of disease progression or death from any cause. The analysis is based on the full analysis set and the per-protocol set. The median PFS and its 95% CI were estimated using the Kaplan-Meier method, and survival curves were plotted.
4 secondary outcomes
OS
Time frame: 2 years
ORR
Time frame: 1 year
DCR
Time frame: 1 year
DOR
Time frame: 1 year
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 2 Dec 2025.
- 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.
Kefeng Ding, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Cetuximab β；Fruquintinib；, Cetuximab β；Fruquintinib；anti-PD1 antibody； and Cetuximab β；Fruquintinib；anti-PD1/CTLA4 antibody in people with Colorectal Neoplasms and RAS, run by Zhejiang University 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 23 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 2 Dec 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 Kefeng Ding, PhD (86-571-87784720, dingkefeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 1 year). 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 2 Dec 2025.