Metastatic Colorectal Cancer (CRC)Phase 2NCT07724223
Fruquintinib Plus Anti-EGFR Antibody for Third-Line Treatment of RAS Wild-Type mCRC
A Phase 2 study testing Fruquintinib plus Cetuximab-beta in people with Metastatic Colorectal Cancer (CRC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study aims to evaluate the effectiveness and safety of combining fruquintinib (an oral anti-angiogenesis drug) with cetuximab-beta (an anti-EGFR antibody) in patients with RAS wild-type metastatic colorectal cancer who have already failed at least two lines of standard treatments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC)
- What is being tested?
- Fruquintinib plus Cetuximab-beta
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2026to 31 Jan 2029
- 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 18-75 years, inclusive.
- Fully informed about the study and willing to sign written informed consent.
- Histologically confirmed metastatic or advanced colorectal adenocarcinoma.
- Tumor confirmed as NRAS, KRAS, and BRAF wild-type.
- At least one measurable lesion according to RECIST 1.1 criteria.
- ECOG performance status of 0-1.
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- Estimated life expectancy ≥ 12 weeks.
- Prior treatment with oxaliplatin- and irinotecan-based therapy, or failure of at least two prior standard regimens.
- Prior treatments must have included fluoropyrimidine, oxaliplatin, and irinotecan (with or without bevacizumab or cetuximab).
- Treatment failure defined as disease progression during therapy or within 3 months after last treatment, or intolerance to toxicity.
- Recurrence within 6 months after adjuvant/neoadjuvant therapy is considered as first-line failure.
- Adequate organ function within 7 days prior to enrollment:
- ANC ≥ 1.5 × 10⁹/L
- Platelets ≥ 80 × 10⁹/L
- Hemoglobin ≥ 8 g/dL
- Total bilirubin ≤ 1.5 × ULN
- AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN in liver metastasis)
- Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min
- INR ≤ 1.5 or APTT ≤ 1.5 × ULN
- No receipt of blood products or growth factors within 14 days prior to enrollment.
- Able and willing to comply with study procedures and follow-up.
Who cannot join
- Unable or unwilling to comply with the study protocol.
- Prior treatment with VEGFR tyrosine kinase inhibitors (e.g., regorafenib).
- Participation in another clinical trial within 4 weeks.
- Systemic anticancer therapy within 4 weeks before enrollment.
- Uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg).
- Any condition that affects drug absorption or inability to take oral medication.
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- Active gastric or duodenal ulcer, ulcerative colitis, or tumor-related active bleeding.
- Positive fecal occult blood (≥ ++) without endoscopic exclusion of bleeding.
- Arterial or deep venous thrombosis within 6 months.
- Significant bleeding within 2 months (melena, hematemesis, hemoptysis).
- Stroke or transient ischemic attack within 12 months.
- Significant cardiovascular disease:
- Acute myocardial infarction within 6 months
- Severe or unstable angina
- Heart failure NYHA class > II
- Clinically significant arrhythmia requiring treatment
- LVEF < 50%
- History of other malignancies within 5 years (except adequately treated in-situ cancers or early non-invasive cancers).
- Uncontrolled active infection, including HBV or HCV (HBV DNA ≥ 1×10⁴ copies/mL or >2000 IU/mL).
- Pregnant or breastfeeding women.
- Urine protein ≥ 2+ or 24-hour urine protein > 1.0 g.
- HIV-positive individuals.
- Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.
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
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Yongkun Sun, (+86)010-87788800
About this study
Official title: A Phase II Study of Fruquintinib Combined With Anti-EGFR Monoclonal Antibody in Third-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer
This study aims to evaluate the effectiveness and safety of combining fruquintinib (an oral anti-angiogenesis drug) with cetuximab-beta (an anti-EGFR antibody) in patients with RAS wild-type metastatic colorectal cancer who have already failed at least two lines of standard treatments.
Standard therapies for metastatic colorectal cancer often include fluorouracil, oxaliplatin, and irinotecan. However, many patients eventually experience disease progression, and treatment options become limited. Fruquintinib and cetuximab-beta work through different mechanisms: fruquintinib blocks tumor blood vessel growth, while cetuximab-beta blocks EGFR-related cancer cell growth signals. Using these two drugs together may provide additional benefit for patients whose cancer no longer responds to other treatments.
Read more
This study will enroll 46 patients who meet the eligibility criteria. All participants will take fruquintinib by mouth once daily (3 weeks on and 1 week off) and receive cetuximab-beta by intravenous infusion every 2 weeks. Treatment will continue until the cancer progresses or side effects become intolerable.
Doctors will monitor tumor changes every 8 weeks using CT or MRI scans and will also collect blood samples over time to measure circulating tumor DNA (ctDNA), which may help track how the cancer responds to treatment. Safety will be assessed through physical exams, lab tests, and monitoring of side effects.
The main goal of the study is to determine the objective response rate (ORR)-how many patients experience measurable tumor shrinkage. Secondary goals include progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety outcomes.
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Being tested
- Fruquintinib plus Cetuximab-beta
- Keywords
- Metastatic Colorectal Cancer, RAS Wild-Type, Fruquintinib, Cetuximab-beta, Targeted Therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib plus Cetuximab-betaDrug
Patients receive fruquintinib 5 mg orally once daily for 3 consecutive weeks followed by 1 week off in a 4-week cycle. Cetuximab-beta is administered intravenously at 500 mg/m² every 2 weeks. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. Tumor assessments are performed every 8 weeks using RECIST 1.1 criteria. Safety is monitored through physical examinations, laboratory tests, vital signs, ECG, echocardiography, and adverse event reporting. Circulating tumor DNA (ctDNA) is collected at baseline, every 8 weeks during treatment, at progression, and 4-6 weeks after progression to evaluate molecular response and resistance dynamics. The regimen is designed for patients with metastatic colorectal cancer who previously failed standard fluoropyrimidine, oxaliplatin, and irinotecan-based therapies and who have RAS wild-type tumors.
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib Plus Cetuximab-beta | Experimental | Not described Receives: Drug: Fruquintinib plus Cetuximab-beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of patients with a confirmed complete response or partial response using RECIST 1.1
Measured: From the date of first study treatment until documented disease progression, initiation of a new anticancer therapy, or discontinuation of study treatment, whichever occurs first, up to 24 months.
Secondary outcomes (4)
Progression-Free Survival (PFS)
The time from the date of the first administration of this regimen to the date of first documented disease progression or death due to any cause.
Measured: From the date of first study treatment to the first documented disease progression or death from any cause, whichever occurs first, up to 24 months.
Disease Control Rate (DCR)
Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
Measured: From the date of first study treatment until documented disease progression, initiation of a new anticancer therapy, or discontinuation of study treatment, whichever occurs first, up to 24 months.
Overall Survival (OS)
Time from first dose of study treatment until death from any cause.
Measured: From the date of first study treatment to death from any cause, up to 36 months.
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Number and proportion of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Safety assessments include laboratory tests, vital signs, 12-lead electrocardiography, echocardiography, and clinically significant physical examination findings.
Measured: From the first dose of study treatment through 90 days after the last dose, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start16 Jan 2026
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Jan 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 Cancer (CRC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongkun Sun, Principal investigator, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724223
- Sponsor's protocol ID
- NCCH0046
- Status last verified
- Jan 2026
- First submitted
- 14 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Fruquintinib Combined With Anti-EGFR Monoclonal Antibody in Third-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07724223
- Acronym / sponsor ID
- NCCH0046
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Keywords
- Metastatic Colorectal Cancer, RAS Wild-Type, Fruquintinib, Cetuximab-beta, Targeted Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 24 Jul 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.
This study aims to evaluate the effectiveness and safety of combining fruquintinib (an oral anti-angiogenesis drug) with cetuximab-beta (an anti-EGFR antibody) in patients with RAS wild-type metastatic colorectal cancer who have already failed at least two lines of standard treatments.
Standard therapies for metastatic colorectal cancer often include fluorouracil, oxaliplatin, and irinotecan. However, many patients eventually experience disease progression, and treatment options become limited. Fruquintinib and cetuximab-beta work through different mechanisms: fruquintinib blocks tumor blood vessel growth, while cetuximab-beta blocks EGFR-related cancer cell growth signals. Using these two drugs together may provide additional benefit for patients whose cancer no longer responds to other treatments.
This study will enroll 46 patients who meet the eligibility criteria. All participants will take fruquintinib by mouth once daily (3 weeks on and 1 week off) and receive cetuximab-beta by intravenous infusion every 2 weeks. Treatment will continue until the cancer progresses or side effects become intolerable.
Doctors will monitor tumor changes every 8 weeks using CT or MRI scans and will also collect blood samples over time to measure circulating tumor DNA (ctDNA), which may help track how the cancer responds to treatment. Safety will be assessed through physical exams, lab tests, and monitoring of side effects.
The main goal of the study is to determine the objective response rate (ORR)-how many patients experience measurable tumor shrinkage. Secondary goals include progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib Plus Cetuximab-beta | Experimental | Drug: Fruquintinib plus Cetuximab-beta |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age 18-75 years, inclusive.
- Fully informed about the study and willing to sign written informed consent.
- Histologically confirmed metastatic or advanced colorectal adenocarcinoma.
- Tumor confirmed as NRAS, KRAS, and BRAF wild-type.
- At least one measurable lesion according to RECIST 1.1 criteria.
Key exclusion criteria (23 listed)
- Unable or unwilling to comply with the study protocol.
- Prior treatment with VEGFR tyrosine kinase inhibitors (e.g., regorafenib).
- Participation in another clinical trial within 4 weeks.
- Systemic anticancer therapy within 4 weeks before enrollment.
- Uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg).
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 |
|---|---|---|
| Fruquintinib plus Cetuximab-betaPatients receive fruquintinib 5 mg orally once daily for 3 consecutive weeks followed by 1 week off in a 4-week cycle. Cetuximab-beta is administered intravenously at 500 mg/m² every 2 weeks. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. Tumor assessments are performed every 8 weeks using RECIST 1.1 criteria. Safety is monitored through physical examinations, laboratory tests, vital signs, ECG, echocardiography, and adverse event reporting. Circulating tumor DNA (ctDNA) is collected at baseline, every 8 weeks during treatment, at progression, and 4-6 weeks after progression to evaluate molecular response and resistance dynamics. The regimen is designed for patients with metastatic colorectal cancer who previously failed standard fluoropyrimidine, oxaliplatin, and irinotecan-based therapies and who have RAS wild-type tumors. | Drug | Fruquintinib Plus Cetuximab-beta |
Primary outcome
Objective Response Rate (ORR)
Time frame: From the date of first study treatment until documented disease progression, initiation of a new anticancer therapy, or discontinuation of study treatment, whichever occurs first, up to 24 months.
The proportion of patients with a confirmed complete response or partial response using RECIST 1.1
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From the date of first study treatment to the first documented disease progression or death from any cause, whichever occurs first, up to 24 months.
Disease Control Rate (DCR)
Time frame: From the date of first study treatment until documented disease progression, initiation of a new anticancer therapy, or discontinuation of study treatment, whichever occurs first, up to 24 months.
Overall Survival (OS)
Time frame: From the date of first study treatment to death from any cause, up to 36 months.
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: From the first dose of study treatment through 90 days after the last dose, up to 24 months.
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 24 Jul 2026.
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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.
Yongkun Sun principal investigator
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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 Fruquintinib plus Cetuximab-beta in people with Metastatic Colorectal Cancer (CRC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 21 inclusion and 23 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 24 Jul 2026. 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 Yongkun Sun ((+86)010-87788800, hsunyk@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From the date of first study treatment until documented disease progression, initiation of a new anticancer therapy, or discontinuation of study treatment, whichever occurs first, up to 24 months.). 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 24 Jul 2026.