Metastatic Colorectal Cancer (CRC)Phase 2NCT07622550
A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated Advanced Colorectal Cance
A Phase 2 study testing Serplulimab+Fruquintinib+XELOX in people with Metastatic Colorectal Cancer (CRC), run by Jiangsu Cancer Institute & Hospital at 16 sites in China.
Trial summary
This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of Fruquintinib combined With Serplulimab and chemotherapy as first-line treatment for RAS/BRAF-mutated unresectable advanced colorectal cancer. 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?
- Serplulimab+Fruquintinib+XELOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 16 sitesChina
- Study dates
- 15 Jun 2026to 15 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
- 18 to 75 years (inclusive), male or female.
- Diagnosis of advanced unresectable or metastatic colorectal cancer.
- Confirmed RAS/BRAF mutation by testing.
- No prior systemic therapy for unresectable or metastatic colorectal cancer. (Prior adjuvant or neoadjuvant chemotherapy with one regimen is allowed if recurrence occurred ≥6 months after completion of chemotherapy.)
- ECOG 0 - 1.
- Adequate major organ and bone marrow function (without any blood component or cell growth factor support within 14 days before enrollment):
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- Hematology: absolute neutrophil count ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, hemoglobin ≥90 g/L.
- International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN.
- Liver function: total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN (≤5 × ULN in patients with liver metastases).
- Renal function: serum creatinine ≤1.5 × ULN, and creatinine clearance (CCr) ≥50 mL/min.
- Female patients of childbearing potential must have a negative serum pregnancy test within 14 days before treatment. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence) with their partners during the study and for at least 6 months after the last dose
Who cannot join
- - History of hypersensitivity to any anti-angiogenic targeted agent, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.
- Untreated central nervous system (CNS) metastases.
- Major surgery or severe trauma within 4 weeks prior to first study drug administration.
- Current use of immunosuppressive agents, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent), and continued use within 2 weeks before enrollment.
- Presence of any active autoimmune disease or history of autoimmune disease.
- History of other malignancies within the past 5 years, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Known inherited or acquired bleeding/thrombotic tendency (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or currently receiving thrombolytic or anticoagulant therapy.
- Currently active bleeding or significant bleeding tendency within 3 months (i.e., patients at high risk of bleeding).
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites
Changzhou Tumor Hospital (Changzhou Fourth People's Hospital)
Changzhou, Jiangsu, 213000
Yong Liu, 13921033137
Liyang People's Hospital
Changzhou, Jiangsu, 213000
Liqun Zhu, 13626255262
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213000
Huaian First People's Hospital
Huai'an, Jiangsu, 223000
Xiaomin Zhong, 13912074971
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222000
First Affiliated Hospital of Nanjing Medical Unviersity
Nanjing, Jiangsu, 210000
Jing Sun, 13914704178
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, 210000
Liang'jun Zhu, 13505199123, zhulj98@foxmail.com
Nantong University Cancer Hospital
Nantong, Jiangsu, 226000
Lei Yang, 158 5139 8092
The First People's Hospital of Nantong
Nantong, Jiangsu, 226000
Liang zhang, 137 0629 5558
Changshu No.2 People's Hospital
Suzhou, Jiangsu, 215000
Yulan Gu, 13812971602
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
jianming Shi, 138 1525 9001
Wuxi Huishan District People's Hospital
Wuxi, Jiangsu, 214000
Ning Ding, 177 0617 8690
Jiangyin People's Hospital
Wuxi, Jiangsu, 214400
Qiong Wang, 136 0616 8002
Xuzhou First People's Hospital
Xuzhou, Jiangsu, 221000
Taifeng Liu, 13685183529
Yangzhou University Affiliated Jiangdu People's Hospital
Yangzhou, Jiangsu, 225000
Min Liao, 15952578622
Yizheng People's Hospital
Yangzhou, Jiangsu, 225000
About this study
This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of Fruquintinib combined With Serplulimab and chemotherapy as first-line treatment for RAS/BRAF-mutated unresectable advanced colorectal cancer. The study plans to enroll 80 patients with RAS/BRAF-mutated unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with Fruquintinib combined With Serplulimab and chemotherapy . The primary endpoint of the study is PFS, and secondary endpoints include ORR, DCR, OS, and safety.
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Being tested
- Serplulimab+Fruquintinib+XELOX
- Keywords
- RAS/BRAF-mutated
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serplulimab+Fruquintinib+XELOXDrug
combination regimen of fruquintinib, serplulimab, and XELOX for 6-8 cycles. The dosing schedule is as follows: Fruquintinib: 3 mg/day, QD, PO, daily for 21 days of each 28-day cycle Serplulimab: 4.5 mg/kg, D1, intravenous infusion, Q3W XELOX ：Oxaliplatin: 130 mg/m², intravenous infusion over 0-2 hours, D1, Q3W Capecitabine: 1000 mg/m², PO, BID, D1-14, Q3W
Maintenance therapy administration:
After completion of the combination therapy, subjects with a response assessment of CR, PR, or SD, , will enter the maintenance phase:
Fruquintinib、Serplulimaband Capecitabine , until diseas progression, unacceptable toxicity, or voluntary withdrawal of informed consent
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib Combined With Serplulimab and XELOX | Experimental | This study consists of two phases: combination and maintenance therapy. combination therapy administration： After screening and enrollment, patients will receive a first-line combination regimen of fruquintinib, serplulimab, and XELOX for 6-8 cycles.
Maintenance therapy administration:
After completion of the combination therapy, subjects with a response assessment of CR, PR, or SD, , will enter the maintenance phase:
Fruquintinib、Serplulimaband Capecitabine , until diseas progression, unacceptable toxicity, or voluntary withdrawal of informed consent NOTE: If lesions become resectable, surgical treatment should be performed. Receives: Drug: Serplulimab+Fruquintinib+XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed Progression-Free Survival（PFS）
The time from the start of treatment in cancer patients to the observation of disease progression or death from any cause
Measured: From enrollment to the end of treatment at 18 months
Secondary outcomes (4)
Investigator-assessed Objective Response Rate（ORR）
CR+PR
Measured: From enrollment to the end of treatment at 18 months
Overall Survival（OS）
Time from enrollment to death from any cause
Measured: From enrollment to the end of treatment at 36 months
DCR
CR+PR+SD
Measured: From enrollment to the end of treatment at 24 months
AEs
Safety analysis will be based on data from the safety population. It will primarily involve descriptive statistical analysis, with tables describing the adverse events that occurred in this study.
Measured: Through study completion, an average of 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 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 (CRC)Studies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liangjun Zhu M.M., Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622550
- Sponsor's protocol ID
- HMPL-013-FLAG-C133
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated Advanced Colorectal Cance
- ClinicalTrials.gov ID
- NCT07622550
- Acronym / sponsor ID
- HMPL-013-FLAG-C133
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Keywords
- RAS/BRAF-mutated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 3 Jun 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 is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of Fruquintinib combined With Serplulimab and chemotherapy as first-line treatment for RAS/BRAF-mutated unresectable advanced colorectal cancer. The study plans to enroll 80 patients with RAS/BRAF-mutated unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with Fruquintinib combined With Serplulimab and chemotherapy . The primary endpoint of the study is PFS, and secondary endpoints include ORR, DCR, OS, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib Combined With Serplulimab and XELOX | Experimental | Drug: Serplulimab+Fruquintinib+XELOXThis study consists of two phases: combination and maintenance therapy. combination therapy administration： After screening and enrollment, patients will receive a first-line combination regimen of fruquintinib, serplulimab, and XELOX for 6-8 cycles. Maintenance therapy administration: After completion of the combination therapy, subjects with a response assessment of CR, PR, or SD, , will enter the maintenance phase: Fruquintinib、Serplulimaband Capecitabine , until diseas progression, unacceptable toxicity, or voluntary withdrawal of informed consent NOTE: If lesions become resectable, surgical treatment should be performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 to 75 years (inclusive), male or female.
- Diagnosis of advanced unresectable or metastatic colorectal cancer.
- Confirmed RAS/BRAF mutation by testing.
- No prior systemic therapy for unresectable or metastatic colorectal cancer. (Prior adjuvant or neoadjuvant chemotherapy with one regimen is allowed if recurrence occurred ≥6 months after completion of chemotherapy.)
- ECOG 0 - 1.
Key exclusion criteria (8 listed)
- - History of hypersensitivity to any anti-angiogenic targeted agent, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.
- Untreated central nervous system (CNS) metastases.
- Major surgery or severe trauma within 4 weeks prior to first study drug administration.
- Current use of immunosuppressive agents, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent), and continued use within 2 weeks before enrollment.
- Presence of any active autoimmune disease or history of autoimmune disease.
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 |
|---|---|---|
| Serplulimab+Fruquintinib+XELOXcombination regimen of fruquintinib, serplulimab, and XELOX for 6-8 cycles. The dosing schedule is as follows: Fruquintinib: 3 mg/day, QD, PO, daily for 21 days of each 28-day cycle Serplulimab: 4.5 mg/kg, D1, intravenous infusion, Q3W XELOX ：Oxaliplatin: 130 mg/m², intravenous infusion over 0-2 hours, D1, Q3W Capecitabine: 1000 mg/m², PO, BID, D1-14, Q3W Maintenance therapy administration: After completion of the combination therapy, subjects with a response assessment of CR, PR, or SD, , will enter the maintenance phase: Fruquintinib、Serplulimaband Capecitabine , until diseas progression, unacceptable toxicity, or voluntary withdrawal of informed consent | Drug | Fruquintinib Combined With Serplulimab and XELOX |
Primary outcome
Investigator-assessed Progression-Free Survival（PFS）
Time frame: From enrollment to the end of treatment at 18 months
The time from the start of treatment in cancer patients to the observation of disease progression or death from any cause
4 secondary outcomes
Investigator-assessed Objective Response Rate（ORR）
Time frame: From enrollment to the end of treatment at 18 months
Overall Survival（OS）
Time frame: From enrollment to the end of treatment at 36 months
DCR
Time frame: From enrollment to the end of treatment at 24 months
AEs
Time frame: Through study completion, an average of 30 weeks
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab+Fruquintinib+XELOX in people with Metastatic Colorectal Cancer (CRC), run by Jiangsu Cancer Institute & Hospital at 16 sites 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 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 Liang'jun Zhu (13505199123, zhulj98@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed Progression-Free Survival（PFS） (time frame: From enrollment to the end of treatment at 18 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 3 Jun 2026.