Colorectal Adenocarcinoma Metastatic in the LiverPhase 2NCT07815288
Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy for Unresectable Colorectal Liver-Limited Metastases
A Phase 2 study testing Retlirafusp alfa Combined with Targeted Therapy and Chemotherapy in people with Colorectal Adenocarcinoma Metastatic in the Liver, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This is a single-center, open-label, exploratory phase II trial to evaluate efficacy and safety of Retlirafusp alfa (PD-L1/TGF-βRII bispecific fusion protein) combined with standard first-line targeted-chemotherapy as conversion therapy in adult patients with initially unresectable microsatellite-stable (MSS/pMMR)… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Colorectal Adenocarcinoma Metastatic in the Liver
- What is being tested?
- Retlirafusp alfa Combined with Targeted Therapy and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 Dec 2029
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent before any trial-related procedure.
- Age ≥18 and ≤79 years, male or female.
- Histopathologically confirmed colorectal adenocarcinoma; liver metastasis confirmed by pathology or imaging.
- No prior first-line systemic therapy (targeted, immunotherapy, systemic chemotherapy) specifically for liver metastases.
- At least 1 measurable lesion per RECIST 1.1.
- Multidisciplinary-team-confirmed initially unresectable colorectal liver metastases (cannot achieve R0/R1 resection; or predicted future remnant liver volume < 30 %; or insufficient hepatic inflow/outflow). Patients with extra-hepatic metastases (excluding brain / bone metastases) amenable to local therapy are eligible.
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- Microsatellite-stable (MSS) / mismatch-repair-proficient (pMMR) confirmed by IHC or PCR.
- ECOG Performance Status 0-1.
- Expected survival ≥12 weeks.
- No urgent-surgery indications (e.g., primary-tumor bleeding, obstruction).
- Adequate organ function within 14 days prior to first study-drug:
- ANC ≥1.5 × 10⁹/L; Platelets ≥75 × 10⁹/L; Hb > 70 g/L
- Total bilirubin ≤1.5 × ULN; Albumin ≥28.0 g/L
- AST / ALT ≤5 × ULN
- Creatinine ≤1.5 × ULN; Cockcroft-Gault creatinine clearance ≥60 mL/min
- INR / PT ≤1.5 × ULN
- Females of reproductive potential / males with reproductive-potential partners agree to highly-effective contraception starting 7 days prior first dose until 24 weeks after last dose.
- Serum pregnancy test negative within 7 days before first dose (women of child-bearing potential).
- Willing and able to comply with all trial visits, treatment and assessments.-
Who cannot join
- 1. Inability to tolerate systemic chemotherapy or subsequent surgery. 2. Liver metastases occurring during or within 6 months after completion of oxaliplatin-based adjuvant chemotherapy for primary colorectal tumor.
- 3. Major surgery within 6 weeks before study entry; severe trauma / non-healing wounds / fractures.
- 4. Myocardial infarction, unstable angina, coronary-artery-bypass-graft within prior 3 months; NYHA class III-IV heart failure.
- 5. Prior treatment with immune-checkpoint-inhibitors (anti-PD-1/PD-L1, anti-CTLA-4 etc.).
- 6. Concurrent or prior other malignancy whose expected survival is shorter than colorectal-liver-metastasis prognosis.
- 7. History of allogeneic hematopoietic-stem-cell or solid-organ transplant (except corneal transplant).
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- 8. History of moderate-severe hypersensitivity / anaphylaxis to antibody-based therapeutics.
- 9. Clinically-significant bleeding diathesis or major bleeding episode within prior 3 months (e.g., gastrointestinal bleeding, esophageal varices, hematemesis, hemoptysis).
- 10. Symptomatic large-volume ascites / pleural effusion / pericardial effusion requiring intervention.
- 11. Primary-tumor perforation, abdominal infection occurring within prior 3 months without adequate management.
- 12. Known hypersensitivity to active ingredients or excipients of study drugs. 13. Active peptic ulcer, gastrointestinal obstruction, active GI bleeding, perforation, malabsorption, uncontrolled inflammatory bowel disease.
- 14. Pregnant or lactating women. 15. Concurrent participation in another interventional clinical trial. 16. Any other condition judged by investigator to make subject unsuitable for trial participation.
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
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Kun Wang, +86 13910726401, wang-kun@vip.sina.com
About this study
Official title: Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy as Conversion Therapy for Initially Unresectable Colorectal Cancer Liver Metastases: An Exploratory Phase II Study
This is a single-center, open-label, exploratory phase II trial to evaluate efficacy and safety of Retlirafusp alfa (PD-L1/TGF-βRII bispecific fusion protein) combined with standard first-line targeted-chemotherapy as conversion therapy in adult patients with initially unresectable microsatellite-stable (MSS/pMMR) colorectal adenocarcinoma liver metastases. Two pre-defined cohorts are enrolled: Cohort 1 for RAS/BRAF wild-type left-sided primary tumor (mFOLFOX6 + cetuximab + Retlirafusp alfa); Cohort 2 for RAS/BRAF-mutant or right-sided primary tumor (CAPEOX + bevacizumab + Retlirafusp alfa).
- Being tested
- Retlirafusp alfa Combined with Targeted Therapy and Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retlirafusp alfa Combined with Targeted Therapy and ChemotherapyDrug
Cohort 1 (RAS/BRAF wild-type, left-sided primary colon cancer):
- Retlirafusp alfa 1800 mg IV D1 every 3 weeks
- Cetuximab 500 mg/m² IV D1 every 2 weeks
- mFOLFOX6: Oxaliplatin 85 mg/m² IV D1 q2w; Leucovorin 400 mg/m² IV D1 q2w; 5-FU 400 mg/m² IV bolus D1 q2w plus 2400 mg/m² 48-h continuous infusion q2w.
Cohort 2 (RAS/BRAF mutant OR RAS/BRAF wild-type right-sided primary colon cancer):
- Retlirafusp alfa 1800 mg IV D1 every 3 weeks
- Bevacizumab 7.5 mg/kg IV D1 every 3 weeks
- CAPEOX: Oxaliplatin 130 mg/m² IV D1 q3w; Capecitabine 1000 mg/m² orally twice daily D1-14 q3w.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm (2-cohort single-group） | Experimental | Not described Receives: Drug: Retlirafusp alfa Combined with Targeted Therapy and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The proportion of subjects achieving complete response or partial response, assessed by investigators according to RECIST 1.1 criteria.
Measured: Following 3 or 6 cycles (each cycle is ~21 days) of the treatment, approximately 9 or 18 weeks overall
Secondary outcomes (5)
Major Pathological Response Rate
Measured: Following 3 or 6 cycles (each cycle is ~21 days) of the treatment, approximately 9 or 18 weeks overall
Surgical Conversion Rate
The proportion of subjects with successful conversion surgery. The criteria for successful conversion are as follows: evaluation of liver metastases achieves partial response after the conversion therapy; liver tumor-free status can be achieved through surgical resection ± ablation or stereotactic radiotherapy, with a residual liver volume exceeding 40%; liver function is classified as Child-Pugh Class A, and other liver function and laboratory parameters meet surgical and anesthesia requirements.
Measured: Following 3 or 6 cycles (each cycle is ~21 days) of the treatment, approximately 9 or 18 weeks overall
Progression-free Survival
The time from the initiation of treatment until disease progression or death from any cause, whichever occurs first.
Measured: assessed up to 18 months
Overall Survival
Description: The time from the initiation of treatment until death from any cause.
Measured: assessed up to 18 months
Safety
Incidence, severity (NCI-CTCAE v5.0) of treatment-emergent adverse events (TEAE), treatment-related adverse events (TRAE), immune-related adverse events (irAE), serious adverse events (SAE), and post-operative complications.
Measured: From first dose through 90 days after last study-drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Adenocarcinoma Metastatic in the LiverStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Kun, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815288
- Sponsor's protocol ID
- 2026YJZ114
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy as Conversion Therapy for Initially Unresectable Colorectal Cancer Liver Metastases: An Exploratory Phase II Study
- ClinicalTrials.gov ID
- NCT07815288
- Acronym / sponsor ID
- 2026YJZ114
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 11 Sep 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.
This is a single-center, open-label, exploratory phase II trial to evaluate efficacy and safety of Retlirafusp alfa (PD-L1/TGF-βRII bispecific fusion protein) combined with standard first-line targeted-chemotherapy as conversion therapy in adult patients with initially unresectable microsatellite-stable (MSS/pMMR) colorectal adenocarcinoma liver metastases. Two pre-defined cohorts are enrolled: Cohort 1 for RAS/BRAF wild-type left-sided primary tumor (mFOLFOX6 + cetuximab + Retlirafusp alfa); Cohort 2 for RAS/BRAF-mutant or right-sided primary tumor (CAPEOX + bevacizumab + Retlirafusp alfa).
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 (2-cohort single-group） | Experimental | Drug: Retlirafusp alfa Combined with Targeted Therapy and Chemotherapy |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed written informed consent before any trial-related procedure.
- Age ≥18 and ≤79 years, male or female.
- Histopathologically confirmed colorectal adenocarcinoma; liver metastasis confirmed by pathology or imaging.
- No prior first-line systemic therapy (targeted, immunotherapy, systemic chemotherapy) specifically for liver metastases.
- At least 1 measurable lesion per RECIST 1.1.
Key exclusion criteria (12 listed)
- 1. Inability to tolerate systemic chemotherapy or subsequent surgery. 2. Liver metastases occurring during or within 6 months after completion of oxaliplatin-based adjuvant chemotherapy for primary colorectal tumor.
- 3. Major surgery within 6 weeks before study entry; severe trauma / non-healing wounds / fractures.
- 4. Myocardial infarction, unstable angina, coronary-artery-bypass-graft within prior 3 months; NYHA class III-IV heart failure.
- 5. Prior treatment with immune-checkpoint-inhibitors (anti-PD-1/PD-L1, anti-CTLA-4 etc.).
- 6. Concurrent or prior other malignancy whose expected survival is shorter than colorectal-liver-metastasis prognosis.
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 |
|---|---|---|
| Retlirafusp alfa Combined with Targeted Therapy and ChemotherapyCohort 1 (RAS/BRAF wild-type, left-sided primary colon cancer): * Retlirafusp alfa 1800 mg IV D1 every 3 weeks * Cetuximab 500 mg/m² IV D1 every 2 weeks * mFOLFOX6: Oxaliplatin 85 mg/m² IV D1 q2w; Leucovorin 400 mg/m² IV D1 q2w; 5-FU 400 mg/m² IV bolus D1 q2w plus 2400 mg/m² 48-h continuous infusion q2w. Cohort 2 (RAS/BRAF mutant OR RAS/BRAF wild-type right-sided primary colon cancer): * Retlirafusp alfa 1800 mg IV D1 every 3 weeks * Bevacizumab 7.5 mg/kg IV D1 every 3 weeks * CAPEOX: Oxaliplatin 130 mg/m² IV D1 q3w; Capecitabine 1000 mg/m² orally twice daily D1-14 q3w. | Drug | Experimental Arm (2-cohort single-group） |
Primary outcome
Objective Response Rate
Time frame: Following 3 or 6 cycles (each cycle is ~21 days) of the treatment, approximately 9 or 18 weeks overall
The proportion of subjects achieving complete response or partial response, assessed by investigators according to RECIST 1.1 criteria.
5 secondary outcomes
Major Pathological Response Rate
Time frame: Following 3 or 6 cycles (each cycle is ~21 days) of the treatment, approximately 9 or 18 weeks overall
Surgical Conversion Rate
Time frame: Following 3 or 6 cycles (each cycle is ~21 days) of the treatment, approximately 9 or 18 weeks overall
Progression-free Survival
Time frame: assessed up to 18 months
Overall Survival
Time frame: assessed up to 18 months
Safety
Time frame: From first dose through 90 days after last study-drug administration.
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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 Retlirafusp alfa Combined with Targeted Therapy and Chemotherapy in people with Colorectal Adenocarcinoma Metastatic in the Liver, run by Peking University Cancer Hospital & Institute 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 19 inclusion and 12 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 11 Sep 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 Kun Wang (+86 13910726401, wang-kun@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Following 3 or 6 cycles (each cycle is ~21 days) of the treatment, approximately 9 or 18 weeks overall). 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 11 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.