Colorectal Cancer Liver MetastasisPhase 2NCT06788171
PULSAR Combined With PD-1 Ab and Chemotherapy Plus Bev. for CRLM
A Phase 2 study testing Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy, Bevacizumab and Capecitabine in people with Colorectal Cancer Liver Metastasis, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
To explore Progression-Free-Survival(FPS) of PULSAR(personalized ultrafractionated stereotactic adaptive radiotherapy) combined with PD-1 Ab and Chemotherapy plus Bevacizumabfor CRLM Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Liver Metastasis
- What is being tested?
- Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy, Bevacizumab and Capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2026to 1 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, any gender.
- Pathologically confirmed colorectal adenocarcinoma with liver metastases from colorectal cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate organ function, no contraindications to radiotherapy, or immunotherapy.
- Estimated life expectancy of more than 3 months.
- No obvious indications for emergent surgery due to primary tumor bleeding, obstruction, or similar conditions.
Show all 13Show fewer
- At least one radiographically measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Microsatellite/mismatch repair status MSS/pMMR.
- No prior anti-tumor therapy for colorectal cancer, including radiotherapy, chemotherapy, or surgery.
- No prior immunotherapy.
- Women of childbearing potential or men with partners of childbearing potential agree to use highly effective contraception (annual failure rate <1%) from 7 days before the first dose through 24 weeks after the last dose.
- Ability and willingness to comply with study visits, treatment schedules, laboratory testing, and other protocol-specified procedures throughout the study.
- Signed written informed consent.
Who cannot join
- Pregnant or lactating women.
- Pathological diagnosis of signet ring cell carcinoma.
- History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
- Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
- Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
- Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
Show all 11Show fewer
- Patients with autoimmune diseases.
- Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
- Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10^9/L; platelets ≥100×10^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin <1.5 times the upper limit of normal; serum creatinine <1 times the upper limit of normal; serum albumin ≥30g/L.
- Known deficiency of dihydropyrimidine dehydrogenase (DPD).
- Allergy to any investigational drug components.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Sha Huang, MD, +86-13763820570, huangsha0210@163.com
MD
About this study
Official title: A Phase II Trial of PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) Combined With PD-1 Ab and Chemotherapy Plus Bevacizumab for Colorectal Cancer Liver Metastasis
To explore Progression-Free-Survival(FPS) of PULSAR(personalized ultrafractionated stereotactic adaptive radiotherapy) combined with PD-1 Ab and Chemotherapy plus Bevacizumabfor CRLM
- Conditions
- Colorectal Cancer Liver Metastasis
- Being tested
- Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy, Bevacizumab, Capecitabine, Oxaliplatin, Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Ultrafractionated Stereotactic Adaptive RadiotherapyRadiation
PULSAR (SBRT): A targeted radiation therapy delivering 5-10 Gy/fraction every 3 weeks (q3w) to the gross tumor volume (GTV), for 3 times.
BevacizumabDrug
Bevacizumab: 5mg/kg, d1, q3w, 6 cycles.
CapecitabineDrug
Capecitabine: 1000mg/m2, d1-14, bid, q3w, 6 cycles.
OxaliplatinDrug
Oxaliplatin: 130mg/m2, d1, q3w, 6 cycles.
SintilimabDrug
Sintilimab: 200mg, d1, q3w, 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy | Experimental | Interventions:
1. Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy)
2. Drug: Bevacizumab
3. Drug: Capecitabine
4. Drug: Oxaliplatin
5. Drug: Sintilimab Receives: Radiation: Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy; Drug: Bevacizumab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free-Survival
Measured: From enrollment to 36 month
Secondary outcomes (3)
Adverse Reactions
Measured: From enrollment to 36 month
Overall Survival (OS)
Measured: From enrollment to 36 month
Objective Response Rate (ORR)
Measured: From enrollment to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start9 May 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 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 Liver MetastasisStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788171
- Sponsor's protocol ID
- LIVERT
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2025
- Last updated
- 1 Oct 2026
- Results posted
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) Combined With PD-1 Ab and Chemotherapy Plus Bevacizumab for Colorectal Cancer Liver Metastasis
- ClinicalTrials.gov ID
- NCT06788171
- Acronym / sponsor ID
- LIVERT
- Conditions
- Colorectal Cancer Liver Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 9 May 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 23 Jan 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 explore Progression-Free-Survival(FPS) of PULSAR(personalized ultrafractionated stereotactic adaptive radiotherapy) combined with PD-1 Ab and Chemotherapy plus Bevacizumabfor CRLM
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy | Experimental | Radiation: Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy, Drug: Bevacizumab, Drug: Capecitabine, Drug: Oxaliplatin, Drug: SintilimabInterventions: 1. Radiation: PULSAR(Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) 2. Drug: Bevacizumab 3. Drug: Capecitabine 4. Drug: Oxaliplatin 5. Drug: Sintilimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-75 years, any gender.
- Pathologically confirmed colorectal adenocarcinoma with liver metastases from colorectal cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate organ function, no contraindications to radiotherapy, or immunotherapy.
- Estimated life expectancy of more than 3 months.
Key exclusion criteria (11 listed)
- Pregnant or lactating women.
- Pathological diagnosis of signet ring cell carcinoma.
- History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
- Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
- Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
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 |
|---|---|---|
| Personalized Ultrafractionated Stereotactic Adaptive RadiotherapyPULSAR (SBRT): A targeted radiation therapy delivering 5-10 Gy/fraction every 3 weeks (q3w) to the gross tumor volume (GTV), for 3 times. | Radiation | PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy |
| BevacizumabBevacizumab: 5mg/kg, d1, q3w, 6 cycles. | Drug | PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy |
| CapecitabineCapecitabine: 1000mg/m2, d1-14, bid, q3w, 6 cycles. | Drug | PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy |
| OxaliplatinOxaliplatin: 130mg/m2, d1, q3w, 6 cycles. | Drug | PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy |
| SintilimabSintilimab: 200mg, d1, q3w, 6 cycles. | Drug | PULSAR combined with PD-1 Ab and Bevacizumab plus Chemotherapy |
Primary outcome
Progression-free-Survival
Time frame: From enrollment to 36 month
3 secondary outcomes
Adverse Reactions
Time frame: From enrollment to 36 month
Overall Survival (OS)
Time frame: From enrollment to 36 month
Objective Response Rate (ORR)
Time frame: From enrollment to 36 month
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 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer Liver Metastasis
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 2
Circulating Tumor DNA Methylation-Guided Adjuvant Therapy Decision-Making in Patients With Resectable Colorectal Cancer Liver Metastases After Resection
Colorectal Cancer Liver Metastases (CRLM), ctDNA
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
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 Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy, Bevacizumab and Capecitabine in people with Colorectal Cancer Liver Metastasis, run by Fujian Cancer Hospital 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 13 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: looking for participants now, as of the sponsor's last update on 1 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 Sha Huang, MD (+86-13763820570, huangsha0210@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free-Survival (time frame: From enrollment to 36 month). 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 1 Oct 2026.