Colorectal CancerPhase 2NCT05954429
A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study
A Phase 2 study testing serplulimab and Fruquintinib in people with Colorectal Cancer, run by Fudan University at 2 sites in China.
Trial summary
The aim of this clinical trial is to learn about efficacy of fruquintinib combined with serplulimab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main purpose is to explore efficacy, safety and tolerability of the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- serplulimab and Fruquintinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jul 2023to 31 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, both sexes;
- Patients with histologically or cytologically confirmed unresectable and metastatic CRC
- non-liver-limited metastasis: including no liver metastasis or liver metastasis accompanied by other metastatic lesions, such as lung metastasis, peritoneal metastasis, etc
- Before enrollment, the tumor tissue was pMMR by immunohistochemistry, or MSS or MSI-L by PCR or NGS;
- Have received standard treatment in the past and developed disease progression or intolerance to standard treatment based on RECIST 1.1 during or after standard treatment. Standard treatment should include:
- Fluorouracil, oxaliplatin and irinotecan
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- With or without anti-VEGF monoclonal antibody
- For RAS wild-type patients, combined with anti-EGFR monoclonal antibody
- For patients with BRAF mutations, BRAF inhibitor therapy is recommended when drugs are available
- Patients with ECOG score of 0-2 and expected survival time ≥3 months, patients who can cooperate to observe adverse reactions and efficacy;
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Good organ function:
- neutrophil ≥1.5*109/L; Platelet ≥100*109/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl;
- Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal, T3 and T4 in the normal range;
- bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤ 2 times the upper limit of normal;
- Serum creatinine ≤ 1.5 times the upper limit of normal, creatinine clearance ≥60ml/min;
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of the normal range, unless the patient is receiving anticoagulant therapy and the PT value is within the intended range for anticoagulant therapy;
- Activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal;
- There were no serious concomitant diseases that could make the survival time less than 5 years;
- Negative pregnancy test in female subjects (for female patients of childbearing potential); Infertile female patients;
- Male patients of childbearing potential and female patients of childbearing potential and at risk of pregnancy must agree to use adequate contraception for the entire duration of the study and for 12 months after receiving treatment with the protocol;
- Signed and dated informed consent indicating that the patient has been informed about all relevant aspects of the study;
- Patients who are willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other study procedures;
- Willing to comply with the arrangement during the study period can not participate in any other clinical research on drugs and medical devices
Who cannot join
- Pathological diagnosis of other intestinal tumors, such as gastrointestinal stromal tumor;
- Tumor tissues were dMMR detected by immunohistochemistry, or MSI-H detected by PCR or NGS
- Prior treatment with PD-1 antibody, PD-L1 antibody, or CTLA-4 antibody;
- Previous or concurrent history of other malignant tumors, excluding adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;
- Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); It does not include autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes on stable doses of insulin; Vitiligo or cured childhood asthma/allergy without any intervention in adulthood;
- A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation or allogeneic bone marrow transplantation;
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- Contraindications to antiangiogenic drugs (such as active bleeding, gastrointestinal bleeding, hemoptysis, etc.);
- History of interstitial lung disease (excluding radiation pneumonitis without steroid treatment) and non-infectious pneumonia;
- Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment;
- The subject has active hepatitis B (HBV DNA ≥2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the assay)
- Severe cardiopulmonary and renal dysfunction;
- Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- A history of psychotropic substance abuse, alcohol or drug abuse;
- Other factors that may affect subject safety or trial compliance as judged by the investigator. Severe medical conditions requiring concomitant treatment (including mental illness), serious laboratory abnormalities, or other family or social factors
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Junjie Peng, 021-64175590, pengjj67@hotmail.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Junjie Peng, MD, PhD, 86-18017317122, pengjj67@hotmail.com
Yaqi Li, MD, PhD, 86-15902194450, yaqili702@hotmail.com
About this study
The aim of this clinical trial is to learn about efficacy of fruquintinib combined with serplulimab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main purpose is to explore efficacy, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including ctDNA, TPS, CPS, tumor mutation burden, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, etc.) and the efficacy and drug resistance mechanism will be analyzed, which could provide reference for determining the advantaged group.
Read the detailed description
Serplulimab is an anti-PD-1 monoclonal antibody, and fruquintinib is a tyrosine kinase inhibitor that inhibits tumor angiogenesis. Studies have shown that immunotherapy combined with fruquintinib has preliminary efficacy in the treatment of colorectal cancer. Whether serplulimab combined with fruquintinib can improve the prognosis of patients with colorectal cancer remains to be determined. Therefore, the study is to evaluate the efficacy and safety of serplulimab combination with fruquintinib in patients with microsatellite stabilized mCRC who have failed standard therapy.
- Conditions
- Colorectal Cancer
- Being tested
- serplulimab, Fruquintinib
- Keywords
- MSS, serplulimab, fruquintinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serplulimabDrug
Serplulimab is an innovative monoclonal antibody targeting PD-1, developed by Shanghai Henlius Biotech, Inc.
300 mg, q3w Other name: HLX10
FruquintinibDrug
5mg (QD) orally for 2 weeks, 1 week off, repeated every 3 weeks until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab+Fruquintinib | Experimental | Participants will receive serplulimab 300 mg every 3 weeks (Q3W) concurrently with fruquintinib regimen: 5mg (QD) orally for 2 weeks, 1 week off, repeated every 3 weeks. Treatment repeats every 3 weeks until disease progression or intolerable toxicity. Receives: Drug: serplulimab; Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
The proportion of participants whose best outcome is complete remission or partial remission
Measured: 3 years
Secondary outcomes (3)
overall survival (OS)
The time between the start of the participants' treatment and their death from any cause
Measured: 3 years
progression-free survival (PFS)
Time from initiation of treatment to disease progression or death from any cause
Measured: 3 years
adverse events
Assessment of the safety profile of regimen according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start20 Jul 2023
- Primary completion28 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Peng, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954429
- Sponsor's protocol ID
- FDCRC87PJJ
- Status last verified
- Jan 2026
- First submitted
- 13 Jul 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study
- ClinicalTrials.gov ID
- NCT05954429
- Acronym / sponsor ID
- FDCRC87PJJ
- Conditions
- Colorectal Cancer
- Keywords
- MSS, serplulimab, fruquintinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical trial is to learn about efficacy of fruquintinib combined with serplulimab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main purpose is to explore efficacy, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including ctDNA, TPS, CPS, tumor mutation burden, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, etc.) and the efficacy and drug resistance mechanism will be analyzed, which could provide reference for determining the advantaged group.
Detailed description
Serplulimab is an anti-PD-1 monoclonal antibody, and fruquintinib is a tyrosine kinase inhibitor that inhibits tumor angiogenesis. Studies have shown that immunotherapy combined with fruquintinib has preliminary efficacy in the treatment of colorectal cancer. Whether serplulimab combined with fruquintinib can improve the prognosis of patients with colorectal cancer remains to be determined. Therefore, the study is to evaluate the efficacy and safety of serplulimab combination with fruquintinib in patients with microsatellite stabilized mCRC who have failed standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab+Fruquintinib | Experimental | Drug: serplulimab, Drug: FruquintinibParticipants will receive serplulimab 300 mg every 3 weeks (Q3W) concurrently with fruquintinib regimen: 5mg (QD) orally for 2 weeks, 1 week off, repeated every 3 weeks. Treatment repeats every 3 weeks until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥18 years old, both sexes;
- Patients with histologically or cytologically confirmed unresectable and metastatic CRC
- non-liver-limited metastasis: including no liver metastasis or liver metastasis accompanied by other metastatic lesions, such as lung metastasis, peritoneal metastasis, etc
- Before enrollment, the tumor tissue was pMMR by immunohistochemistry, or MSS or MSI-L by PCR or NGS;
- Have received standard treatment in the past and developed disease progression or intolerance to standard treatment based on RECIST 1.1 during or after standard treatment. Standard treatment should include:
Key exclusion criteria (14 listed)
- Pathological diagnosis of other intestinal tumors, such as gastrointestinal stromal tumor;
- Tumor tissues were dMMR detected by immunohistochemistry, or MSI-H detected by PCR or NGS
- Prior treatment with PD-1 antibody, PD-L1 antibody, or CTLA-4 antibody;
- Previous or concurrent history of other malignant tumors, excluding adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;
- Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); It does not include autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes on stable doses of insulin; Vitiligo or cured childhood asthma/allergy without any intervention in adulthood;
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 |
|---|---|---|
| serplulimabSerplulimab is an innovative monoclonal antibody targeting PD-1, developed by Shanghai Henlius Biotech, Inc. 300 mg, q3w Other name: HLX10 | Drug | Serplulimab+Fruquintinib |
| Fruquintinib5mg (QD) orally for 2 weeks, 1 week off, repeated every 3 weeks until disease progression or intolerable toxicity. | Drug | Serplulimab+Fruquintinib |
Primary outcome
objective response rate (ORR)
Time frame: 3 years
The proportion of participants whose best outcome is complete remission or partial remission
3 secondary outcomes
overall survival (OS)
Time frame: 3 years
progression-free survival (PFS)
Time frame: 3 years
adverse events
Time frame: 3 years
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 22 Jan 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.
2 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 and Fruquintinib in people with Colorectal Cancer, run by Fudan University at 2 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 24 inclusion and 14 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: 3 years). 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 22 Jan 2026.