Advanced Colorectal CarcinomaPhase 2NCT06521866
Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer
A Phase 2 study testing Serplulimab, Chemotherapy and SABR in people with Advanced Colorectal Carcinoma and Immunotherapy, run by Fudan University at 10 sites in China.
Trial summary
Study Title: A Prospective, Randomized, Phase II, Multicenter Clinical Study of Serplulimab Combined with Targeted Therapy, Chemotherapy, and Optional Radiotherapy in Advanced Colorectal Cancer Study Objective: To explore the efficacy and safety of immune checkpoint inhibitor combined with targeted therapy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Carcinoma, Immunotherapy
- What is being tested?
- Serplulimab, Chemotherapy and SABR
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 10 sitesChina
- Study dates
- 1 Mar 2025to 1 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, any gender;
- Histologically confirmed metastatic colorectal cancer (Stage IV, UICC), with initially unresectable metastases or refusal of surgery;
- Primary tumor located in the distal transverse colon, descending colon, sigmoid colon, and rectum, and RAS (KRAS and NRAS) and BRAF wild-type (Cohorts A and B);
- Primary tumor located in the cecum, ascending colon, and proximal transverse colon, and RAS (KRAS and NRAS) mutant-type (Cohorts C and D);
- Treatment-naive patients who have not received standard anti-tumor therapy;
- At least one measurable tumor lesion per RECIST 1.1 criteria;
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- ECOG performance status of 0-1;
- Patients with an expected survival time of ≥ 3 months and good organ function:
- (1) Neutrophils ≥ 1.5 * 10^9/L; platelets ≥ 100 * 10^9/L; hemoglobin ≥ 9 g/dL; serum albumin ≥ 3 g/dL;
- (2) Thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN), T3 and T4 within normal ranges;
- (3) Bilirubin ≤ 1.5 times ULN; ALT and AST ≤ 2 times ULN;
- (4) Serum creatinine ≤ 1.5 times ULN, creatinine clearance rate ≥ 60 mL/min;
- (5) International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, unless the patient is receiving anticoagulant therapy and PT is within the expected therapeutic range of anticoagulants;
- (6) Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN;
- Female patients of childbearing potential must have a negative pregnancy test; female patients not of childbearing potential; male patients of reproductive potential and female patients of reproductive potential and at risk of pregnancy must agree to use adequate contraception throughout the study period, continuing until 12 months after the last dose of study treatment;
- Signed and dated informed consent form indicating that the patient has been informed of all pertinent aspects of the study;
- Patients willing and able to comply with visit schedule, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Pathologically diagnosed with other intestinal tumors, such as gastrointestinal stromal tumors;
- No testing for RAS mutation status;
- Resectable metastases or patients wishing to undergo metastasectomy;
- Prior systemic therapy. Systemic therapy includes all of the following: chemotherapy agents such as fluoropyrimidines, irinotecan, and oxaliplatin, VEGF monoclonal antibodies (e.g., bevacizumab), EGFR monoclonal antibodies (cetuximab or panitumumab), small molecule TKIs, immune checkpoint inhibitors, etc.;
- Uncontrolled active bleeding from the primary tumor or bowel obstruction;
- Contraindications to immune checkpoint inhibitors;
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- Allergy to the therapeutic drugs and/or their excipients;
- Previous treatment with PD-1 antibodies, PD-L1 antibodies, or CTLA-4 antibodies;
- Received any form of radiation therapy within 4 weeks prior to enrollment;
- Previous or concurrent other malignancies, except adequately treated non-melanoma skin cancer, in situ cervical cancer, or papillary thyroid carcinoma;
- Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); except autoimmune-mediated hypothyroidism on stable doses of thyroid replacement hormone, type I diabetes on stable doses of insulin, vitiligo, or childhood asthma/allergies that have resolved and do not require intervention in adulthood;
- History of immunodeficiency, including HIV-positive, or other acquired/congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;
- History of interstitial lung disease (excluding radiation pneumonitis not treated with steroids), non-infectious pneumonia;
- Active tuberculosis infection identified by history or CT scan, or history of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago but without proper treatment;
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10^4 copies/mL), active hepatitis C (HCV antibody positive and HCV-RNA above the detection limit);
- Severe dysfunction of the heart, lungs, or kidneys;
- Hypertension not well controlled by antihypertensive medications (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
- History of substance abuse, alcoholism, or drug addiction;
- Any other factors judged by the investigator to potentially affect the safety or compliance of the patient with the study, such as serious concomitant disease (including mental illness), serious laboratory abnormalities, or other familial or social factors.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
Anyang Cancer Hospital
Anyang, 455000
Yanjun Wang
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Shen Guan
- Not yet recruiting
Huai'an Second People's Hospital
Huaian, Jiangsu, 223001
Haijian Zhao
- Not yet recruiting
Qianfoshan Hospital of Shandong Province
Jinan, Shandong, 250000
Hui Yang
- Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650000
Xinyi Cai
- Not yet recruiting
Lanzhou Military Region General Hospital
Lanzhou, Gansu, 730000
Shoucheng Ma
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200030
Dawei Li, 13774201693, li_dawei@fudan.edu.cn
- Not yet recruiting
Taian City Central Hospital
Taian, Shandong, 271000
Gang Cui
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Guoqiang Su
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Jinbo Liu
About this study
Official title: A Prospective, Randomized, Phase II, Multicenter Clinical Study of Serplulimab Combined with First-Line Targeted Therapy and Chemotherapy with or Without Radiation in the First-Line Treatment of Advanced Colorectal Cancer
Study Title:
A Prospective, Randomized, Phase II, Multicenter Clinical Study of Serplulimab Combined with Targeted Therapy, Chemotherapy, and Optional Radiotherapy in Advanced Colorectal Cancer
Read more
Study Objective:
To explore the efficacy and safety of immune checkpoint inhibitor combined with targeted therapy and chemoradiotherapy in locally advanced unresectable or metastatic colorectal cancer.
Study Population:
Patients with left-sided wild-type, right-sided, or RAS-mutant advanced colorectal cancer who have not received systemic treatment.
Study Endpoints:
Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), safety, and R0 resection rate.
Study Design:
Prospective, randomized Phase II clinical study.
- Conditions
- Advanced Colorectal Carcinoma, Immunotherapy
- Being tested
- Serplulimab, Chemotherapy, SABR, Targeted therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
IV 3 mg/kg on Day 1, q2w
ChemotherapyDrug
Induction therapy：Oxaliplatin: 85 mg/m² IV on Day 1 Leucovorin (LV): 400 mg/m² IV on Day 1 5-FU: 400 mg/m² IV bolus on Day 1, then 2400 mg/m² continuous IV infusion over 46-48 hours
Maintenance therapy:
Leucovorin (LV): 400 mg/m² IV on Day 1 5-FU: 400 mg/m² IV bolus on Day 1, then 2400 mg/m² continuous IV infusion over 46-48 hours
SABRRadiation
SABR: 25-60 Gy/5 Fx
Targeted therapyDrug
Cetuximab: 400 mg/m² IV on Day 1, then 250 mg/m² IV weekly ; Bevacizumab: 5 mg/kg IV on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A (Left-sided wild-type):
Induction Treatment (12 cycles):
Serplulimab: IV 3 mg/kg on Day 1, q2w Cetuximab: 400 mg/m² IV infusion (1st infusion >2 hours, then 250 mg/m² IV infusion ≥60 min), weekly mFOLFOX6: Oxaliplatin: 85 mg/m² IV over 2 hrs, Day 1 LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w
Maintenance therapy:
Serplulimab: IV 3 mg/kg on Day 1, q2w Cetuximab: 400 mg/m² IV infusion (1st infusion >2 hours, then 250 mg/m² IV infusion ≥60 min), weekly 5-FU/LV: LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w Receives: Drug: Serplulimab; Drug: Chemotherapy; Drug: Targeted therapy |
| Group B | Experimental | Group B (Left-sided wild-type):
One cycle of Serplulimab combined with Cetuximab and chemotherapy, followed by Stereotactic ablative radiotherapy（SABR: 25-60 Gy/5 Fx）, then continued Serplulimab combined with Cetuximab and chemotherapy. Receives: Drug: Serplulimab; Drug: Chemotherapy; Radiation: SABR; Drug: Targeted therapy |
| Group C | Experimental | Group C (Right-sided or RAS-mutant): Induction Treatment (12 cycles):
Serplulimab: IV 3 mg/kg on Day 1, q2w Bevacizumab: 5 mg/kg IV on Day 1, q2w mFOLFOX6: Oxaliplatin: 85 mg/m² IV over 2 hrs, Day 1 LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w
Maintenance Treatment:
Serplulimab: IV 3 mg/kg on Day 1, q2w Bevacizumab: 5 mg/kg IV on Day 1, q2w 5-FU/LV: LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w Receives: Drug: Serplulimab; Drug: Chemotherapy; Drug: Targeted therapy |
| Group D | Experimental | Group D (Right-sided or RAS-mutant): One cycle of Serplulimab combined with Bevacizumab and chemotherapy, followed by Stereotactic ablative radiotherapy（SABR: 25-60 Gy/5 Fx）, then continued Serplulimab combined with Bevacizumab and chemotherapy. Receives: Drug: Serplulimab; Drug: Chemotherapy; Radiation: SABR; Drug: Targeted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: 2 year
Secondary outcomes (3)
OS
Overall Survial
Measured: 2 year
ORR
Objective Response Rate
Measured: 2 year
Incidence of Side Effect
Side Effect
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Mar 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Dawei, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521866
- Sponsor's protocol ID
- VICTORY CRC
- Status last verified
- Mar 2025
- First submitted
- 22 Jul 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Phase II, Multicenter Clinical Study of Serplulimab Combined with First-Line Targeted Therapy and Chemotherapy with or Without Radiation in the First-Line Treatment of Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06521866
- Acronym / sponsor ID
- VICTORY CRC
- Conditions
- Advanced Colorectal Carcinoma, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 26 Jul 2024 (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.
Study Title:
A Prospective, Randomized, Phase II, Multicenter Clinical Study of Serplulimab Combined with Targeted Therapy, Chemotherapy, and Optional Radiotherapy in Advanced Colorectal Cancer
Study Objective:
To explore the efficacy and safety of immune checkpoint inhibitor combined with targeted therapy and chemoradiotherapy in locally advanced unresectable or metastatic colorectal cancer.
Study Population:
Patients with left-sided wild-type, right-sided, or RAS-mutant advanced colorectal cancer who have not received systemic treatment.
Study Endpoints:
Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), safety, and R0 resection rate.
Study Design:
Prospective, randomized Phase II clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Serplulimab, Drug: Chemotherapy, Drug: Targeted therapyGroup A (Left-sided wild-type): Induction Treatment (12 cycles): Serplulimab: IV 3 mg/kg on Day 1, q2w Cetuximab: 400 mg/m² IV infusion (1st infusion >2 hours, then 250 mg/m² IV infusion ≥60 min), weekly mFOLFOX6: Oxaliplatin: 85 mg/m² IV over 2 hrs, Day 1 LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w Maintenance therapy: Serplulimab: IV 3 mg/kg on Day 1, q2w Cetuximab: 400 mg/m² IV infusion (1st infusion >2 hours, then 250 mg/m² IV infusion ≥60 min), weekly 5-FU/LV: LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w |
| Group B | Experimental | Drug: Serplulimab, Drug: Chemotherapy, Radiation: SABR, Drug: Targeted therapyGroup B (Left-sided wild-type): One cycle of Serplulimab combined with Cetuximab and chemotherapy, followed by Stereotactic ablative radiotherapy（SABR: 25-60 Gy/5 Fx）, then continued Serplulimab combined with Cetuximab and chemotherapy. |
| Group C | Experimental | Drug: Serplulimab, Drug: Chemotherapy, Drug: Targeted therapyGroup C (Right-sided or RAS-mutant): Induction Treatment (12 cycles): Serplulimab: IV 3 mg/kg on Day 1, q2w Bevacizumab: 5 mg/kg IV on Day 1, q2w mFOLFOX6: Oxaliplatin: 85 mg/m² IV over 2 hrs, Day 1 LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w Maintenance Treatment: Serplulimab: IV 3 mg/kg on Day 1, q2w Bevacizumab: 5 mg/kg IV on Day 1, q2w 5-FU/LV: LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w |
| Group D | Experimental | Drug: Serplulimab, Drug: Chemotherapy, Radiation: SABR, Drug: Targeted therapyGroup D (Right-sided or RAS-mutant): One cycle of Serplulimab combined with Bevacizumab and chemotherapy, followed by Stereotactic ablative radiotherapy（SABR: 25-60 Gy/5 Fx）, then continued Serplulimab combined with Bevacizumab and chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years, any gender;
- Histologically confirmed metastatic colorectal cancer (Stage IV, UICC), with initially unresectable metastases or refusal of surgery;
- Treatment-naive patients who have not received standard anti-tumor therapy;
- At least one measurable tumor lesion per RECIST 1.1 criteria;
- ECOG performance status of 0-1;
Key exclusion criteria (19 listed)
- Pathologically diagnosed with other intestinal tumors, such as gastrointestinal stromal tumors;
- No testing for RAS mutation status;
- Resectable metastases or patients wishing to undergo metastasectomy;
- Prior systemic therapy. Systemic therapy includes all of the following: chemotherapy agents such as fluoropyrimidines, irinotecan, and oxaliplatin, VEGF monoclonal antibodies (e.g., bevacizumab), EGFR monoclonal antibodies (cetuximab or panitumumab), small molecule TKIs, immune checkpoint inhibitors, etc.;
- Uncontrolled active bleeding from the primary tumor or bowel obstruction;
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 |
|---|---|---|
| SerplulimabIV 3 mg/kg on Day 1, q2w | Drug | Group A, Group B, Group C, Group D |
| ChemotherapyInduction therapy：Oxaliplatin: 85 mg/m² IV on Day 1 Leucovorin (LV): 400 mg/m² IV on Day 1 5-FU: 400 mg/m² IV bolus on Day 1, then 2400 mg/m² continuous IV infusion over 46-48 hours Maintenance therapy: Leucovorin (LV): 400 mg/m² IV on Day 1 5-FU: 400 mg/m² IV bolus on Day 1, then 2400 mg/m² continuous IV infusion over 46-48 hours | Drug | Group A, Group B, Group C, Group D |
| SABRSABR: 25-60 Gy/5 Fx | Radiation | Group B, Group D |
| Targeted therapyCetuximab: 400 mg/m² IV on Day 1, then 250 mg/m² IV weekly ; Bevacizumab: 5 mg/kg IV on Day 1 | Drug | Group A, Group B, Group C, Group D |
Primary outcome
PFS
Time frame: 2 year
Progression Free Survival
3 secondary outcomes
OS
Time frame: 2 year
ORR
Time frame: 2 year
Incidence of Side Effect
Time frame: 2 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 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
10 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, Chemotherapy and SABR in people with Advanced Colorectal Carcinoma and Immunotherapy, run by Fudan University at 10 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 17 inclusion and 19 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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 Dawei Li, PhD (13774201693, li_dawei@fudan.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: 2 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 14 Mar 2025.