Patients With Initially Unresectable MSS-type Advanced Colorectal Cancer With Liver and/or Lung and Peritoneal MetastasisPhase 2NCT07512674

Modified Short-Course Radiotherapy Combined With Immunochemotherapy and Targeted Therapy as First-Line Treatment for MSS Metastatic Colorectal Cancer

A Phase 2 study testing Receiving lymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy and bevacizumab targeted therapy in people with Patients With Initially Unresectable MSS-type Advanced Colorectal Cancer With Liver and/or Lung and Peritoneal Metastasis, run by Sir Run Run Shaw Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This is a single-arm interventional study targeting patients with initially unresectable MSS-type advanced colorectal cancer with liver and/or lung and peritoneal metastasis. Patients will receive lymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy, and bevacizumab… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Patients With Initially Unresectable MSS-type Advanced Colorectal Cancer With Liver and/or Lung and Peritoneal Metastasis
What is being tested?: Receiving lymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy and bevacizumab targeted therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteChina
Study dates: 26 Feb 2026to Mar 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

1. Voluntarily participate in this study and provide written informed consent. Good compliance and ability to comply with follow-up procedures.
2. Age ≥ 18 years. 3. Primary tumor located in the colon or rectum. 4. Histologically confirmed adenocarcinoma; pMMR by immunohistochemistry or MSS by genetic testing.
5. Metastatic disease confirmed by contrast-enhanced or non-contrast CT or contrast-enhanced MRI within 3 weeks before enrollment; at least one measurable lesion in the liver and/or lung, or peritoneal cavity (RECIST 1.1); metastatic lesions assessed as initially unresectable by multidisciplinary discussion.
6. ECOG performance status 0-1. 7. Life expectancy ≥ 3 months. 8. Adequate organ and bone marrow function:
Hemoglobin ≥ 6.0 mmol/L,
Absolute neutrophil count ≥ 1.5 ×10⁹/L,

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Platelet count ≥ 100 ×10⁹/L;
Renal function: serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 30 mL/min;
Hepatic function: serum bilirubin ≤ 2 × ULN, serum transaminases ≤ 5 × ULN. 9. No contraindications to surgery.

Who cannot join

1. Prior treatment with PD-1, PD-L1, or other immune checkpoint inhibitors. 2. Prior receipt of any anti-tumor therapy for colorectal cancer, including radiotherapy, chemotherapy, or tumor resection surgery.
3. Microsatellite instability-high (MSI-H) or DNA mismatch repair deficiency (dMMR).
4. Presence of brain metastases. 5. Participation in another clinical trial of anti-tumor agents within 4 weeks prior to enrollment.
6. History of hypersensitivity to monoclonal antibodies, any component of tislelizumab, capecitabine, oxaliplatin, or bevacizumab.
7. Receipt of local treatments including transarterial chemoembolization, microwave ablation, radiofrequency ablation, SBRT, or metastasectomy for liver or lung metastases within 4 weeks prior to enrollment.
8. Confirmed immunodeficiency disease or active autoimmune disease, including but not limited to systemic lupus erythematosus, inflammatory bowel disease, myasthenia gravis, autoimmune hepatitis, rheumatoid arthritis, multiple sclerosis, glomerulonephritis, vasculitis; use of other immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 4 weeks prior to enrollment.

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9. Known human immunodeficiency virus (HIV) infection; clinically significant liver disease including viral hepatitis [active HBV infection (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), hepatitis C (positive anti-HCV antibody with HCV RNA above the lower limit of detection)].
10. Uncontrolled hypertension, or inadequate blood pressure control despite treatment with ≥ 3 antihypertensive agents.
11. Disease with severe bleeding risk such as gastrointestinal bleeding, bleeding diathesis, or thrombotic disease requiring long-term oral anticoagulants or antiplatelet agents.
12. Uncontrolled cardiac symptoms or diseases including but not limited to:
NYHA class ≥ II heart failure;
unstable angina;
myocardial infarction within 1 year;
clinically significant supraventricular or ventricular arrhythmias that are uncontrolled or poorly controlled despite intervention.
13. Severe infection (CTCAE grade > 2) within 4 weeks prior to the first study drug administration, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; active pulmonary inflammation on baseline chest imaging; signs or symptoms of infection or requirement for oral or intravenous antibiotics within 14 days before the first study drug administration (excluding prophylactic antibiotics); active tuberculosis confirmed by history or CT, history of active tuberculosis within 1 year prior to enrollment, or history of active tuberculosis more than 1 year prior without standard treatment.
14. Diagnosis of another malignancy within 5 years prior to the first study drug administration, except malignancies with low risk of metastasis or death (5-year survival > 90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
15. Pregnant or lactating female. 16. Other vulnerable populations, including patients with psychiatric disorders, cognitive impairment, or critical illness.
17. Any other condition judged by the investigator that may lead to premature study discontinuation, such as other serious diseases (including psychiatric disorders) requiring concurrent treatment, alcoholism, drug abuse, family or social factors that may affect subject safety or compliance.

Trial locations and contacts

1 site in 1 country.

China1 site

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang

Other trials in China

About this study

Official title: A Clinical Study of Modified Short-Course Radiotherapy Combined With Tislelizumab, CAPOX Chemotherapy and Bevacizumab as First-Line Treatment for Initially Unresectable Microsatellite Stable Metastatic Colorectal Cancer

Conditions: Patients With Initially Unresectable MSS-type Advanced Colorectal Cancer With Liver and/or Lung and Peritoneal Metastasis
Being tested: Receiving lymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy and bevacizumab targeted therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Receiving lymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy and bevacizumab targeted therapyDrug
Receiving lymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy and bevacizumab targeted therapy

Study groups in NCT07512674
Study group	Role	What they receive
experimental arm	Experimental	Lymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy and bevacizumab targeted therapy Receives: Drug: Receiving lymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy and bevacizumab targeted therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST criteria
Measured: through study completion, an average of 1 year

Secondary outcomes (3)

Progression Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the date of first study treatment administration to the date of first documented disease progression or death from any cause, whichever occurs first
Measured: through study completion, an average of 1 year
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of patients who achieve confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST criteria.
Measured: through study completion, an average of 1 year
Safety of the study
Safety is evaluated by the incidence, severity, and relationship of adverse events, laboratory abnormalities and life state
Measured: Baseline and up to 8 weeks after completion of chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 2026Mar 2027

First posted6 Apr 2026
Study start26 Feb 2026
Primary completionDec 2026 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Patients With Initially Unresectable MSS-type Advanced Colorectal Cancer With Liver and/or Lung and Peritoneal MetastasisStudies of the same condition, open and under way.
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: 33 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07512674
Sponsor's protocol ID: REACH-M
Status last verified: Feb 2026
First submitted: 3 Mar 2026
Last updated: 6 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study of Modified Short-Course Radiotherapy Combined With Tislelizumab, CAPOX Chemotherapy and Bevacizumab as First-Line Treatment for Initially Unresectable Microsatellite Stable Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07512674
Acronym / sponsor ID: REACH-M
Conditions: Patients With Initially Unresectable MSS-type Advanced Colorectal Cancer With Liver and/or Lung and Peritoneal Metastasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 33 participants (estimated)
Lead sponsor: Sir Run Run Shaw HospitalUniversity, hospital or other
Study start: 26 Feb 2026 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 6 Apr 2026 (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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
experimental arm	Experimental	Drug: Receiving lymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy and bevacizumab targeted therapyLymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy and bevacizumab targeted therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

1. Voluntarily participate in this study and provide written informed consent. Good compliance and ability to comply with follow-up procedures.
2. Age ≥ 18 years. 3. Primary tumor located in the colon or rectum. 4. Histologically confirmed adenocarcinoma; pMMR by immunohistochemistry or MSS by genetic testing.
5. Metastatic disease confirmed by contrast-enhanced or non-contrast CT or contrast-enhanced MRI within 3 weeks before enrollment; at least one measurable lesion in the liver and/or lung, or peritoneal cavity (RECIST 1.1); metastatic lesions assessed as initially unresectable by multidisciplinary discussion.
6. ECOG performance status 0-1. 7. Life expectancy ≥ 3 months. 8. Adequate organ and bone marrow function:

Key exclusion criteria (18 listed)

1. Prior treatment with PD-1, PD-L1, or other immune checkpoint inhibitors. 2. Prior receipt of any anti-tumor therapy for colorectal cancer, including radiotherapy, chemotherapy, or tumor resection surgery.
3. Microsatellite instability-high (MSI-H) or DNA mismatch repair deficiency (dMMR).
4. Presence of brain metastases. 5. Participation in another clinical trial of anti-tumor agents within 4 weeks prior to enrollment.
6. History of hypersensitivity to monoclonal antibodies, any component of tislelizumab, capecitabine, oxaliplatin, or bevacizumab.
7. Receipt of local treatments including transarterial chemoembolization, microwave ablation, radiofrequency ablation, SBRT, or metastasectomy for liver or lung metastases within 4 weeks prior to enrollment.

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
Receiving lymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy and bevacizumab targeted therapyReceiving lymph node-sparing modified short-course radiotherapy combined with tislelizumab, CAPOX chemotherapy and bevacizumab targeted therapy	Drug	experimental arm

Primary outcome

Objective Response Rate (ORR)
Time frame: through study completion, an average of 1 year
Objective Response Rate (ORR) is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST criteria

3 secondary outcomes

Progression Free Survival (PFS)
Time frame: through study completion, an average of 1 year
Disease Control Rate (DCR)
Time frame: through study completion, an average of 1 year
Safety of the study
Time frame: Baseline and up to 8 weeks after completion of chemotherapy

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 6 Apr 2026.

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 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?

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?

Objective Response Rate (ORR) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07512674.

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 6 Apr 2026.