Colorectal Cancer (CRC)Phase 1NCT06882915
Efficacy and Safety of Trifluridine/Tipiracil (TAS-102) Combined With Bevacizumab and Serplulimab in Patients With Metastatic Colorectal Cancer Undergoing Cytoreductive Surgery: A Single-Arm, Single-Center Clinical Study
A Phase 1 study testing Trifluridine/tipiracil (TAS-102) combined with bevacizumab and ptemizumab in people with Colorectal Cancer (CRC), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Colorectal cancer (CRC) is one of the most common malignant tumors. With the rapid development of China's economy, people's living standards have been significantly improved, and lifestyles and dietary structures have changed. Smoking, drinking, high-fat, high-energy diets, etc. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- Trifluridine/tipiracil (TAS-102) combined with bevacizumab and ptemizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2026to 1 May 2027
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had undergone cytoreductive surgery (CC0-1) for colorectal cancer with peritoneal metastases;
- Patients with extra-peritoneal metastatic lesions that were unlikely to affect prognosis in the short term;
- Patients who had failed standard therapies (disease progression or intolerance to oxaliplatin, irinotecan, fluorouracil, or other chemotherapeutic agents) or for whom no effective treatment options were available;
- Patients with histologically and radiologically confirmed peritoneal metastasis from colorectal cancer, with microsatellite stable (MSS) status as determined by genetic testing;
- Age ≥ 18 years at the time of informed consent;
- Estimated life expectancy > 6 months;
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Adequate function of major organs (cardiac, hepatic, and renal);
- Adequate hematological parameters: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, white blood cell count (WBC) ≥ 3.0 × 10⁹/L, hemoglobin ≥ 10 g/dL, and platelet count ≥ 100 × 10⁹/L;
- Adequate biochemical parameters: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; serum creatinine and blood urea nitrogen (BUN) ≤ 1.5 × ULN;
- Ability to comply with the study protocol and follow-up procedures.
Who cannot join
- Refusal to provide informed consent;
- Currently participating in an interventional clinical study, or having received other investigational drugs or devices within 4 weeks prior to enrollment;
- Concurrent malignancy, except for malignancies that have been clinically cured;
- Other severe diseases that, in the investigator's judgment, may affect follow-up compliance or short-term survival;
- Known hypersensitivity to any component of TAS-102, bevacizumab, or serplulimab;
- Uncontrolled brain metastases;
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- Active autoimmune disease;
- Pregnant or lactating women;
- History of psychiatric disorders;
- Uncontrolled comorbidities including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, severe coronary artery disease, or cerebrovascular disease, or any other condition deemed by the investigator to render the patient ineligible for enrollment;
- Any other condition that the investigator considers unsuitable for enrollment.
About this study
Colorectal cancer (CRC) is one of the most common malignant tumors. With the rapid development of China's economy, people's living standards have been significantly improved, and lifestyles and dietary structures have changed. Smoking, drinking, high-fat, high-energy diets, etc. have led to an increase in the incidence of colorectal cancer year by year. Data show that in 2022, there will be 510,000 new cases of colorectal cancer in China, and about 240,000 deaths related to colorectal cancer. Radical surgery is the main initial treatment for early and middle-stage colorectal cancer and some metastatic colorectal cancer. Although the level of surgical treatment of colorectal cancer has been greatly improved and can achieve cure for some patients, its 5-year overall survival rate is only about 60%, and the main cause of death is distant metastasis and recurrence. In recent years, with the in-depth understanding of the treatment mechanism of metastatic colorectal cancer (mCRC), a variety of new treatment options have been proposed and applied in clinical practice in order to improve the quality of life of patients and prolong their survival.
Trifluridine/tipivirine (TAS-102) is a new type of cytotoxic drug that exerts anti-tumor effects by directly incorporating into DNA chains to destroy DNA function. Its mechanism of action is different from that of fluorouracil drugs, and it can resist 5-fluorouracil (5-FU) resistance, providing a new treatment option for mCRC patients. TAS-102 has been approved in China for mCRC patients who have previously received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, as well as those who have previously received or are not suitable for anti-vascular endothelial growth factor (VEGF) therapy and anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type). Bevacizumab, as a monoclonal antibody targeting VEGF, exerts its anti-tumor effect by inhibiting tumor angiogenesis. Putlimumab, as an immune checkpoint inhibitor, enhances the body's immune response to tumors by blocking the PD-1/PD-L1 signaling pathway.
Combination therapy has attracted much attention due to its possible synergistic effect. Studies have shown that TAS-102 combined with bevacizumab can achieve longer overall survival (OS) than TAS-102 monotherapy. In addition, TAS-102 combined with bevacizumab for refractory mCRC has also been approved by the FDA, showing its potential and importance in the treatment of mCRC. Therefore, this study aims to explore the efficacy and safety of TAS-102 combined with bevacizumab and putelimab in patients with mCRC after cytoreductive surgery, in order to provide a more effective treatment for mCRC patients. Through the design of a single-arm, single-center clinical study, we can have a deeper understanding of the efficacy and safety of this combined treatment in a specific patient population, providing a scientific basis for future clinical applications.
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- Trifluridine/tipiracil (TAS-102) combined with bevacizumab and ptemizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifluridine/tipiracil (TAS-102) combined with bevacizumab and ptemizumabDrug
TAS-102: Use at the recommended dose of 35 mg/m² each time, twice a day on the 1st to 5th day and the 8th to 12th day every 28 days, with meals.
Bevacizumab: Once a day on the 1st and 15th day every 28 days, at the recommended dose of 5 mg/kg each time, with meals.
Putlimumab: At the recommended dose of 200 mg/time, intravenous drip, infusion time is 60 minutes, once every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Trifluridine/tipiracil (TAS-102) combined with bevacizumab and serplulimab | Experimental | The treatment regimen consisted of trifluridine/tipiracil (TAS-102) combined with bevacizumab and serplulimab, administered in 14-day cycles.
TAS-102: Administered at the recommended dose of 35 mg/m² twice daily with meals, on Days 1-5 of each 14-day cycle, followed by a treatment-free interval from Days 9-14.
Bevacizumab: Administered intravenously at the recommended dose of 5 mg/kg per infusion, as prescribed, once every 14 days.
Serplulimab: Administered intravenously at the recommended dose of 100 mg per infusion over 30 minutes, once every 14 days. Receives: Drug: Trifluridine/tipiracil (TAS-102) combined with bevacizumab and ptemizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The period from the beginning of treatment to the first occurrence of disease progression or death from any cause. If such situation is not met, the last evaluation date shall be used for analysis. In addition, if the treatment is terminated without confirming the progress of the disease, the imaging examination and follow-up should also be carried out after the treatment is terminated.
Measured: Two Years
Secondary outcomes (4)
Objective Remission Rate (ORR)
The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit. The remission period usually refers to the period from the beginning of curative effect to the confirmation of tumor progression. The objective response rate is generally defined as the sum of complete response plus partial response (CR+PR).
Measured: Two Years
Overall Survival (OS)
The time from the date of treatment to the date of death due to any reason. For patients who survived in the final analysis, the date of the last contact will be recorded.
Measured: Two Years
Treatment response
To evaluate tumor response using imaging examinations (CT/MRI) and tumor shrinkage rate using the response evaluation criteria in solid tumors (RECIST 1.1).
Measured: Two Years
Incidence rate of adverse events
According to NCI CTCAE v5.0
Measured: Baseline before any treatment,3 months after any treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start6 Jun 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The treatment regimen consisted of trifluridine/tipiracil (TAS-102) combined with bevacizumab and serplulimab, administered in 14-day cycles. TAS-102: Administered at the recommended dose of 35 mg/m² twice daily with meals, on Days 1-5 of each 14-day cycle, followed by a treatment-free interval from Days 9-14. Bevacizumab: Administered intravenously at the recommended dose of 5 mg/kg per infusion, as prescribed, once every 14 days. Serplulimab: Administered intravenously at the recommended dose of 100 mg per infusion over 30 minutes, once every 14 days.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882915
- Sponsor's protocol ID
- 2025-0383
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2025
- Last updated
- 8 Jun 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Trifluridine/Tipiracil (TAS-102) Combined With Bevacizumab and Serplulimab in Patients With Metastatic Colorectal Cancer Undergoing Cytoreductive Surgery: A Single-Arm, Single-Center Clinical Study
- ClinicalTrials.gov ID
- NCT06882915
- Acronym / sponsor ID
- 2025-0383
- Conditions
- Colorectal Cancer (CRC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 6 Jun 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 19 Mar 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 (CRC) is one of the most common malignant tumors. With the rapid development of China's economy, people's living standards have been significantly improved, and lifestyles and dietary structures have changed. Smoking, drinking, high-fat, high-energy diets, etc. have led to an increase in the incidence of colorectal cancer year by year. Data show that in 2022, there will be 510,000 new cases of colorectal cancer in China, and about 240,000 deaths related to colorectal cancer. Radical surgery is the main initial treatment for early and middle-stage colorectal cancer and some metastatic colorectal cancer. Although the level of surgical treatment of colorectal cancer has been greatly improved and can achieve cure for some patients, its 5-year overall survival rate is only about 60%, and the main cause of death is distant metastasis and recurrence. In recent years, with the in-depth understanding of the treatment mechanism of metastatic colorectal cancer (mCRC), a variety of new treatment options have been proposed and applied in clinical practice in order to improve the quality of life of patients and prolong their survival.
Trifluridine/tipivirine (TAS-102) is a new type of cytotoxic drug that exerts anti-tumor effects by directly incorporating into DNA chains to destroy DNA function. Its mechanism of action is different from that of fluorouracil drugs, and it can resist 5-fluorouracil (5-FU) resistance, providing a new treatment option for mCRC patients. TAS-102 has been approved in China for mCRC patients who have previously received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, as well as those who have previously received or are not suitable for anti-vascular endothelial growth factor (VEGF) therapy and anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type). Bevacizumab, as a monoclonal antibody targeting VEGF, exerts its anti-tumor effect by inhibiting tumor angiogenesis. Putlimumab, as an immune checkpoint inhibitor, enhances the body's immune response to tumors by blocking the PD-1/PD-L1 signaling pathway.
Combination therapy has attracted much attention due to its possible synergistic effect. Studies have shown that TAS-102 combined with bevacizumab can achieve longer overall survival (OS) than TAS-102 monotherapy. In addition, TAS-102 combined with bevacizumab for refractory mCRC has also been approved by the FDA, showing its potential and importance in the treatment of mCRC. Therefore, this study aims to explore the efficacy and safety of TAS-102 combined with bevacizumab and putelimab in patients with mCRC after cytoreductive surgery, in order to provide a more effective treatment for mCRC patients. Through the design of a single-arm, single-center clinical study, we can have a deeper understanding of the efficacy and safety of this combined treatment in a specific patient population, providing a scientific basis for future clinical applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The treatment regimen consisted of trifluridine/tipiracil (TAS-102) combined with bevacizumab and serplulimab, administered in 14-day cycles. TAS-102: Administered at the recommended dose of 35 mg/m² twice daily with meals, on Days 1-5 of each 14-day cycle, followed by a treatment-free interval from Days 9-14. Bevacizumab: Administered intravenously at the recommended dose of 5 mg/kg per infusion, as prescribed, once every 14 days. Serplulimab: Administered intravenously at the recommended dose of 100 mg per infusion over 30 minutes, once every 14 days.
| Arm | Type | Receives |
|---|---|---|
| Trifluridine/tipiracil (TAS-102) combined with bevacizumab and serplulimab | Experimental | Drug: Trifluridine/tipiracil (TAS-102) combined with bevacizumab and ptemizumabThe treatment regimen consisted of trifluridine/tipiracil (TAS-102) combined with bevacizumab and serplulimab, administered in 14-day cycles. TAS-102: Administered at the recommended dose of 35 mg/m² twice daily with meals, on Days 1-5 of each 14-day cycle, followed by a treatment-free interval from Days 9-14. Bevacizumab: Administered intravenously at the recommended dose of 5 mg/kg per infusion, as prescribed, once every 14 days. Serplulimab: Administered intravenously at the recommended dose of 100 mg per infusion over 30 minutes, once every 14 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who had undergone cytoreductive surgery (CC0-1) for colorectal cancer with peritoneal metastases;
- Patients with extra-peritoneal metastatic lesions that were unlikely to affect prognosis in the short term;
- Patients who had failed standard therapies (disease progression or intolerance to oxaliplatin, irinotecan, fluorouracil, or other chemotherapeutic agents) or for whom no effective treatment options were available;
- Patients with histologically and radiologically confirmed peritoneal metastasis from colorectal cancer, with microsatellite stable (MSS) status as determined by genetic testing;
- Age ≥ 18 years at the time of informed consent;
Key exclusion criteria (11 listed)
- Refusal to provide informed consent;
- Currently participating in an interventional clinical study, or having received other investigational drugs or devices within 4 weeks prior to enrollment;
- Concurrent malignancy, except for malignancies that have been clinically cured;
- Other severe diseases that, in the investigator's judgment, may affect follow-up compliance or short-term survival;
- Known hypersensitivity to any component of TAS-102, bevacizumab, or serplulimab;
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 |
|---|---|---|
| Trifluridine/tipiracil (TAS-102) combined with bevacizumab and ptemizumabTAS-102: Use at the recommended dose of 35 mg/m² each time, twice a day on the 1st to 5th day and the 8th to 12th day every 28 days, with meals. Bevacizumab: Once a day on the 1st and 15th day every 28 days, at the recommended dose of 5 mg/kg each time, with meals. Putlimumab: At the recommended dose of 200 mg/time, intravenous drip, infusion time is 60 minutes, once every 28 days. | Drug | Trifluridine/tipiracil (TAS-102) combined with bevacizumab and serplulimab |
Primary outcome
Progression-free survival (PFS)
Time frame: Two Years
The period from the beginning of treatment to the first occurrence of disease progression or death from any cause. If such situation is not met, the last evaluation date shall be used for analysis. In addition, if the treatment is terminated without confirming the progress of the disease, the imaging examination and follow-up should also be carried out after the treatment is terminated.
4 secondary outcomes
Objective Remission Rate (ORR)
Time frame: Two Years
Overall Survival (OS)
Time frame: Two Years
Treatment response
Time frame: Two Years
Incidence rate of adverse events
Time frame: Baseline before any treatment,3 months after any treatment
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 8 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trifluridine/tipiracil (TAS-102) combined with bevacizumab and ptemizumab in people with Colorectal Cancer (CRC), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 11 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Two 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 8 Jun 2026.