Microsatellite Stable Metastatic Colorectal CancerPhase 2iPULSAR-CRCNCT06841159
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1，Chemotherapy and Target Therapy for Metastatic Colorectal Cancer
A Phase 2 study testing Ultra-fractionated radiation therapy, Sintilimab and Standard systemic therapy in people with Microsatellite Stable Metastatic Colorectal Cancer, run by Fudan University at 1 site in China.
Trial summary
To improve the survival in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) by loco-regional therapy with personalized ultra-fractionated radiation plus immunotherpy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Microsatellite Stable Metastatic Colorectal Cancer
- What is being tested?
- Ultra-fractionated radiation therapy, Sintilimab and Standard systemic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to 30 Sep 2030
- 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
- Patient is 18-75 years old at the time of signing the informed consent form.
- ECOG performance status 0-1.
- Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum.
- Distant metastasis lesions are no more than 10 and all sites of disease can be safely treated based on a pre-plan.
- At least one evaluable metastatic lesion for radiotherapy and evaluation according to RECIST 1.1.
- No prior radiotherapy within 6 month.
Show all 11Show fewer
- Previous system therapy. Patients Group Cohort A: participants who have not previously been treated with first-line chemotherapy. Cohort B: Patients with disease progression after first-line chemotherapy or stopped first-line therapy due to unacceptable toxic effects .
- Has an investigator determined life expectancy of at least 24 weeks.
- Demonstrate adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating factors.
- Non pregnant or lactating patients. Effective contraceptive methods should be used during the study and within 6 months of the last administration.
- Fully informed and willing to provide written informed consent for the trial.
Who cannot join
- History of checkpoint inhibitor therapy.
- Neutrophil< 1.5×109/L, PLT< 100×109/L (PLT< 80×109/L in patients with liver metastasis), or Hb< 90 g/L.
- TBIL > 1.5 ULN, or TBIL > 2.5 ULN in patients with liver metastasis. AST or ALT > 2.5 ULN, or ALT and/or AST > 5 ULN in patients with liver metastasis.
- Cr > 1.5 ULN, or creatinine clearance< 50 mL/min (calculated according to Cockcroft Gault formula).
- APTT > 1.5 ULN, PT > 1.5 ULN (subject to the normal value of the clinical trial research center).
- Serious electrolyte abnormalities.
Show all 18Show fewer
- Urinary protein ≥ 2+, or 24-h urine protein ≥1.0 g/24 h.
- Uncontrolled hypertension: SBP >140 mmHg or DBP > 90 mmHg.
- A history of arterial thrombosis or deep vein thrombosis within 6 months; a history of bleeding or evidence of bleeding tendency within 2 months.
- A history of heart disease within 6 months.
- Uncontrolled malignant pleural effusion, ascites, or pericardial effusion.
- The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years.
- A history of liver disease including, but not limited to, HBV infection or HBV DNA positive (≥1×104/mL), HCV infection or HCV DNA positive (≥1×103/mL),and liver cirrhosis.
- Pregnant or lactating women or women who may be pregnant have a positive pregnancy test before the first medication, or the female participants themselves and their partners who were unwilling to implement strict contraception during the study period.
- The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems.
- Serious mental abnormalities.
- The diameter of brain metastasis is greater than 3 cm or the total volume is greater than 30 cc.
- Clinical or radiological evidence of spinal cord compression, or tumors within 3 mm of the spinal cord on MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase 2 Study of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1, Chemotherapy and Target Therapy for Metastatic Colorectal Cancer(iPULSAR-CRC)
To improve the survival in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) by loco-regional therapy with personalized ultra-fractionated radiation plus immunotherpy.
Read the detailed description
IPULSAR-CRC is a prospective, single-arm, two-cohort, investigator-initiated phase II trial to investigate the efficacy and safety of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) plus sintilimab in combination with standard systemic therapy in paitents with microsatellite stable metastatic colorectal cancer (MSS mCRC). Eligible patients will be assigned to two cohorts according to previous treatment: a first-line cohort A and a second-line cohort B. Patients in both arms will receive PULSAR, administered in 5 fractions of 6-10 Gy each (30-100 Gy total) at 3 week intervals. Sintilimab will be administered 200mg every 3 weeks and schedule to the next day of every pulses of radiation. Standard systemic therapy will be administered based on previous chemotherapy and adverse reactions to chemotherapy agents and at the discretion of the oncologist.The survival benefits, response rates, and adverse effects will be analyzed.
- Being tested
- Ultra-fractionated radiation therapy, Sintilimab, Standard systemic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-fractionated radiation therapyRadiation
Radiation therapy will be delivered every 3 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of sintilimab.
SintilimabDrug
Sintilimab will be given at 200 mg q3w every 3 weeks and schedule to the next day of every pulses of radiation.
Standard systemic therapyDrug
First-line standard systemic therapies in cohort A include: FOLFOX/FOLIRI/XELOX+ bevacizumab, FOLFOX/FOLIRI/XELOX+cetuximab (KRAS/NRAS/BRAF WT and left-sided tumors only).
Second-line standard systemic therapies in cohort B include: FOLFOX/XELOX+ bevacizumab, FOLFOX/XELOX+cetuximab (KRAS/NRAS/BRAF WT), FOLFIRI/irinotecan+raltitrexed/irinotecan/+bevacizumab, FOLFIRI/irinotecan+raltitrexed/irinotecan/+cetuximab (KRAS/NRAS/BRAF WT), based on the previous first-line chemotherapy and adverse events.
| Study group | Role | What they receive |
|---|---|---|
| a first-line cohort A and a second-line cohort B | Experimental | Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) plus sintilimab and standard systemic therapy. Receives: Radiation: Ultra-fractionated radiation therapy; Drug: Sintilimab; Drug: Standard systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
time from the date of start treatment until disease progression or censored at last follow-up or death.
Measured: up to 2 years
Secondary outcomes (5)
Overall Survival (OS)
from the date of start treatment until the date of death from any cause or censored at last follow-up.
Measured: up to 3 year
Objective response rate (ORR)
the proportion of patients with the best response of confirmed complete or partial response according to iRECIST in all metastatic lesions.
Measured: up to 1 year
Disease control rate (DCR)
the proportion of patients with disease control in all metastatic lesions. Disease control is defined as CR, PR, or stable disease (SD) per iRECIST after treatment.
Measured: up to 1 year
Duration of response (DOR)
time from the first documented objective response to disease progression in patients with confirmed response.
Measured: up to 2 years
Adverse events
The percentage of patients with treatment-related acute toxicities as assessed by NCI CTCAE v5.0, from treatment initiation until 90 days upon completion of immunotherapy.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start30 Sep 2024
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microsatellite Stable Metastatic 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
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841159
- Sponsor's protocol ID
- FDRT-2023-421-3540
- Acronym
- iPULSAR-CRC
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2024
- Last updated
- 19 Oct 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) Combined With Anti-PD1, Chemotherapy and Target Therapy for Metastatic Colorectal Cancer(iPULSAR-CRC)
- ClinicalTrials.gov ID
- NCT06841159
- Acronym / sponsor ID
- iPULSAR-CRC / FDRT-2023-421-3540
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 24 Feb 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.
To improve the survival in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) by loco-regional therapy with personalized ultra-fractionated radiation plus immunotherpy.
Detailed description
IPULSAR-CRC is a prospective, single-arm, two-cohort, investigator-initiated phase II trial to investigate the efficacy and safety of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR ) plus sintilimab in combination with standard systemic therapy in paitents with microsatellite stable metastatic colorectal cancer (MSS mCRC). Eligible patients will be assigned to two cohorts according to previous treatment: a first-line cohort A and a second-line cohort B. Patients in both arms will receive PULSAR, administered in 5 fractions of 6-10 Gy each (30-100 Gy total) at 3 week intervals. Sintilimab will be administered 200mg every 3 weeks and schedule to the next day of every pulses of radiation. Standard systemic therapy will be administered based on previous chemotherapy and adverse reactions to chemotherapy agents and at the discretion of the oncologist.The survival benefits, response rates, and adverse effects will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a first-line cohort A and a second-line cohort B | Experimental | Radiation: Ultra-fractionated radiation therapy, Drug: Sintilimab, Drug: Standard systemic therapyPersonalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) plus sintilimab and standard systemic therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is 18-75 years old at the time of signing the informed consent form.
- ECOG performance status 0-1.
- Histopathological confirmed MSS/pMMR adenocarcinoma of the colon or rectum.
- Distant metastasis lesions are no more than 10 and all sites of disease can be safely treated based on a pre-plan.
- At least one evaluable metastatic lesion for radiotherapy and evaluation according to RECIST 1.1.
Key exclusion criteria (18 listed)
- History of checkpoint inhibitor therapy.
- Neutrophil< 1.5×109/L, PLT< 100×109/L (PLT< 80×109/L in patients with liver metastasis), or Hb< 90 g/L.
- TBIL > 1.5 ULN, or TBIL > 2.5 ULN in patients with liver metastasis. AST or ALT > 2.5 ULN, or ALT and/or AST > 5 ULN in patients with liver metastasis.
- Cr > 1.5 ULN, or creatinine clearance< 50 mL/min (calculated according to Cockcroft Gault formula).
- APTT > 1.5 ULN, PT > 1.5 ULN (subject to the normal value of the clinical trial research center).
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 |
|---|---|---|
| Ultra-fractionated radiation therapyRadiation therapy will be delivered every 3 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of sintilimab. | Radiation | a first-line cohort A and a second-line cohort B |
| SintilimabSintilimab will be given at 200 mg q3w every 3 weeks and schedule to the next day of every pulses of radiation. | Drug | a first-line cohort A and a second-line cohort B |
| Standard systemic therapyFirst-line standard systemic therapies in cohort A include: FOLFOX/FOLIRI/XELOX+ bevacizumab, FOLFOX/FOLIRI/XELOX+cetuximab (KRAS/NRAS/BRAF WT and left-sided tumors only). Second-line standard systemic therapies in cohort B include: FOLFOX/XELOX+ bevacizumab, FOLFOX/XELOX+cetuximab (KRAS/NRAS/BRAF WT), FOLFIRI/irinotecan+raltitrexed/irinotecan/+bevacizumab, FOLFIRI/irinotecan+raltitrexed/irinotecan/+cetuximab (KRAS/NRAS/BRAF WT), based on the previous first-line chemotherapy and adverse events. | Drug | a first-line cohort A and a second-line cohort B |
Primary outcome
Progression-Free Survival (PFS)
Time frame: up to 2 years
time from the date of start treatment until disease progression or censored at last follow-up or death.
5 secondary outcomes
Overall Survival (OS)
Time frame: up to 3 year
Objective response rate (ORR)
Time frame: up to 1 year
Disease control rate (DCR)
Time frame: up to 1 year
Duration of response (DOR)
Time frame: up to 2 years
Adverse events
Time frame: up to 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 19 Oct 2026.
Related trials for Microsatellite Stable Metastatic Colorectal Cancer
Not yet recruitingPhase 2
Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer
Colorectal Cancer, Metastatic Colorectal Cancer
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
RecruitingPhase 2
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
Ras-mutated Metastatic Colorectal Cancer, mCRC
Active, not recruitingPhase 2
CBX-12 for the Treatment of Metastatic Chemotherapy-Refractory Microsatellite Stable Colorectal Cancer
Metastatic Mismatch Repair Proficient Colorectal Carcinoma, Refractory Mismatch Repair Proficient Colorectal Carcinoma
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
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.
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 Ultra-fractionated radiation therapy, Sintilimab and Standard systemic therapy in people with Microsatellite Stable Metastatic Colorectal Cancer, run by Fudan University 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 11 inclusion and 18 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 19 Oct 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 Zhen Zhang, MD,PhD (86-0204256577200, zhen_zhang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: up to 2 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 19 Oct 2026.