Locally Advanced Rectal Cancer With Liver MetastasesPhase 2NCT06787183
SCRT(Short Course Radiotherapy) Combined With CAPOX Plus QL1706 for Rectal Cancer Liver Metastases
A Phase 2 study testing Short course radiotherapy, Capecitabine and Oxaliplatin in people with Locally Advanced Rectal Cancer With Liver Metastases, run by Fujian Cancer Hospital at 2 sites in China.
Trial summary
To enhance the treatment efficacy of rectal cancer liver metastasis through a multidisciplinary approach of radiotherapy, immunotherapy, and chemotherapy, and to provide a new direction for the combination treatment strategy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer With Liver Metastases
- What is being tested?
- Short course radiotherapy, Capecitabine and Oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2025to 1 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, any gender.
- Pathologically confirmed rectal cancer with liver metastases (stage M1).
- Karnofsky Performance Status ≥70.
- Adequate organ function, no contraindications to radiotherapy, or immunotherapy.
- Microsatellite/mismatch repair status MSS/pMMR.
- No prior chemotherapy or any other anti-tumor treatment before inclusion.
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- No prior immunotherapy.
- Ability to comply with the study protocol during the study period.
- 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.
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- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Fuzhou First General Hospital
Fuzhou, Fujian, 350004
Xiaobin Huang, 86+13860660665
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Hui Li, MD, +8613600855801, lihui770105@126.com
Jinluan Li, MD
About this study
Official title: A Phase II Multicenter Clinical Trail of Efficacy and Safety of Short Course Radiotherapy Combined With CAPOX and PD-1/CTLA-4 Bispecific Antibody QL1706 in Patients With Liver Metastases From Rectal Cancer
To enhance the treatment efficacy of rectal cancer liver metastasis through a multidisciplinary approach of radiotherapy, immunotherapy, and chemotherapy, and to provide a new direction for the combination treatment strategy.
- Being tested
- Short course radiotherapy, Capecitabine, Oxaliplatin, QL1706
- Keywords
- short course radiotheraphy, CAPOX, QL1706 (bifunctional PD1/CTLA4 dual blocker)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short course radiotherapyRadiation
CTV 25Gy/5Fx.
CapecitabineDrug
1000mg/m2, d1-14，bid, q3w, 2 cycles.
OxaliplatinDrug
130mg/m2, d1, q3w, 2 cycles
QL1706Drug
5.0 mg/kg, q3w
| Study group | Role | What they receive |
|---|---|---|
| Short course radiotherapy combined with CAPOX and QL1706 | Experimental | Two cycles of CAPOX combined with QL1706 were followed by a short course of radiotherapy (CTV 25Gy/5f) and finally two cycles of CAPOX and QL1706. Receives: Radiation: Short course radiotherapy; Drug: Capecitabine; Drug: Oxaliplatin; Drug: QL1706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free-Survival
Measured: from enlrollment to 36month
Secondary outcomes (3)
Toxic reaction rate above 3rd degree
Measured: from enlrollment to 36month
relapse-free survival
Measured: from enlrollment to 36month
overall survival
Measured: from enlrollment to 36month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal Cancer With Liver MetastasesStudies 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787183
- Sponsor's protocol ID
- SCARLET
- Status last verified
- Jul 2025
- First submitted
- 16 Jan 2025
- Last updated
- 3 Mar 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Clinical Trail of Efficacy and Safety of Short Course Radiotherapy Combined With CAPOX and PD-1/CTLA-4 Bispecific Antibody QL1706 in Patients With Liver Metastases From Rectal Cancer
- ClinicalTrials.gov ID
- NCT06787183
- Acronym / sponsor ID
- SCARLET
- Keywords
- short course radiotheraphy, CAPOX, QL1706 (bifunctional PD1/CTLA4 dual blocker)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 22 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 enhance the treatment efficacy of rectal cancer liver metastasis through a multidisciplinary approach of radiotherapy, immunotherapy, and chemotherapy, and to provide a new direction for the combination treatment strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short course radiotherapy combined with CAPOX and QL1706 | Experimental | Radiation: Short course radiotherapy, Drug: Capecitabine, Drug: Oxaliplatin, Drug: QL1706Two cycles of CAPOX combined with QL1706 were followed by a short course of radiotherapy (CTV 25Gy/5f) and finally two cycles of CAPOX and QL1706. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 years, any gender.
- Pathologically confirmed rectal cancer with liver metastases (stage M1).
- Karnofsky Performance Status ≥70.
- Adequate organ function, no contraindications to radiotherapy, or immunotherapy.
- Microsatellite/mismatch repair status MSS/pMMR.
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 |
|---|---|---|
| Short course radiotherapyCTV 25Gy/5Fx. | Radiation | Short course radiotherapy combined with CAPOX and QL1706 |
| Capecitabine1000mg/m2, d1-14，bid, q3w, 2 cycles. | Drug | Short course radiotherapy combined with CAPOX and QL1706 |
| Oxaliplatin130mg/m2, d1, q3w, 2 cycles | Drug | Short course radiotherapy combined with CAPOX and QL1706 |
| QL17065.0 mg/kg, q3w | Drug | Short course radiotherapy combined with CAPOX and QL1706 |
Primary outcome
Progression-free-Survival
Time frame: from enlrollment to 36month
3 secondary outcomes
Toxic reaction rate above 3rd degree
Time frame: from enlrollment to 36month
relapse-free survival
Time frame: from enlrollment to 36month
overall survival
Time frame: from enlrollment to 36month
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 3 Mar 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short course radiotherapy, Capecitabine and Oxaliplatin in people with Locally Advanced Rectal Cancer With Liver Metastases, run by Fujian Cancer Hospital at 2 sites 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 9 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Hui Li, MD (+8613600855801, lihui70105@126.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 enlrollment to 36month). 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 3 Mar 2026.