Rectal CancersPhase 2NCT07622771
Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial
A Phase 2 study testing Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX and Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX in people with Rectal Cancers, run by Sun Yat-sen University at 1 site in China.
Trial summary
To explore the efficacy and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancers
- What is being tested?
- Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX and Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2026to 31 Dec 2032
- 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
- Patients or their family members agree to participate in the study and sign the informed consent form;
- Age 18-75 years, male or female;
- Locally advanced rectal adenocarcinoma confirmed by histopathology;
- Clinical stage cT3-4bN0M0 or cTxN+M0, with or without MRF positive, with or without EMVI positive, expected to R0 resection;
- without intestinal obstruction;
- ECOG PS 0-1;
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- expect survival up to 2 years;
- White blood cell count > 3.5×109/L；Platelet count ≥ 100×109/L；Hemoglobin ≥ 80 g/L；
- ALT ≤ 1.5×ULN, AST ≤ 1.5×ULN ；
- Serum creatinine ≤ 100μmol/l,
Who cannot join
- With inguinal lymph node metastasis or lateral lymph node metastasis (lymph node diameter ≥7 mm, or lymph node morphology and MRI features consistent with typical metastatic lymph nodes);
- Arrhythmia requiring antiarrhythmic treatment (except beta-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure exceeding NYHA Class II;
- Severe hypertension poorly controlled with medication;
- History of HIV infection, or active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay);
- Active pulmonary tuberculosis (TB), currently receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening;
- Other active clinically severe infections (NCI-CTCAE Version 5.0);
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- Preoperative evidence of distant metastasis outside the pelvis;
- Cachexia or organ function decompensation.
- History of pelvic or abdominal radiotherapy;
- Multiple primary colorectal cancers;
- Patients with seizures requiring treatment (e.g., corticosteroids or antiepileptic therapy);
- History of other malignancies within 5 years, except cured cervical carcinoma in situ or basal cell carcinoma of the skin;
- Drug abuse, or medical, psychological, or social conditions that may interfere with the patient's participation in the study or affect the evaluation of study results;
- Active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enterocolitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism);
- Receipt of any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment;
- Comorbidities requiring long-term treatment with immunosuppressive agents, or requiring systemic or local administration of corticosteroids at immunosuppressive doses (dose >10 mg/day of prednisone or other glucocorticoids with equivalent efficacy);
- Known or suspected hypersensitivity to the investigational drug, or to any medication administered in relation to this study;
- Any unstable condition that may jeopardize patient safety or compliance;
- Pregnant or lactating women, or women of childbearing potential not using adequate contraception;
- Refusal to sign the informed consent form.
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
Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, P. R. China
Guangzhou, Guangdong, 510000
About this study
To explore the efficacy and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer
- Conditions
- Rectal Cancers
- Being tested
- Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX, Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX
- Keywords
- radiotherapy, immunotherapy, neoadjuvant therapy, rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOXCombination product
Short course radiotherapy, 5 * 5Gy, once a day, 5Gy each time, for 5 days; Adalimumab 1200 mg , D1, q2w, 2 cycles before radiotherapy and 6 cycles after radiotherapy; NALIRIFOX: Oxaliplatin 85 mg/m2, D1; Liposomal irinotecan 60 mg/m2, D1; LV 200 mg/m2; 5-FU 2400 mg/m2, Infusion for 48 hours; Repeat every 2 weeks. 2 cycles before radiotherapy and 6 cycles after radiotherapy;
Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOXCombination product
Long course chemoradiotherapy,50 Gy in 25 fractions, during the same period, capecitabine was 825 mg / m2, twice a day, 5 days a week; Adalimumab 1200 mg , D1, q2w, 2 cycles before radiotherapy and 6 cycles after radiotherapy; NALIRIFOX: Oxaliplatin 85 mg/m2, D1; Liposomal irinotecan 60 mg/m2, D1; LV 200 mg/m2; 5-FU 2400 mg/m2, Infusion for 48 hours; Repeat every 2 weeks. 2 cycles before radiotherapy and 6 cycles after radiotherapy;
| Study group | Role | What they receive |
|---|---|---|
| SCRT combined with Adalimumab and NALIRIFOX | Experimental | Adalimumab combined with NALIRIFOX for two cycles. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: Adalimumab combined with NALIRIFOX for six cycles Receives: Combination Product: Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX |
| LCRT combined with Adalimumab and NALIRIFOX | Experimental | Adalimumab combined with NALIRIFOX for two cycles. Radiotherapy: Long-course chemoradiotherapy (LCRT) (50Gy/25F, during the same period, capecitabine was 825 mg/m2, twice a day, 5 days a week). Consolidation: Adalimumab combined with NALIRIFOX for six cycles Receives: Combination Product: Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate
the number of patients with a pCR for those who underwent surgery and a cCR for those who underwent WW; The pCR was defined as the absence of any tumor cells from the primary tumor and lymph nodes in the specimen after radical surgery (ypT0N0) or the absence of any tumor cells in the lesion after local resection (ypT0).The cCR was defined as the absence of residual disease on DRE, MRI, and endoscopy.
Measured: up to 6 months
Secondary outcomes (6)
Event-Free Survival(EFS) rate
The percentage of patients without disease recurrence or progression or death due to any cause
Measured: an expected average of 5 years
R0 resection rate
The rate of negative margin microscopically
Measured: an expected average of 2 years
ORR[Objective Response Rate]
Proportion of subjects in the analysis population who achieved complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.
Measured: an expected average of 1.5 years
OPR
Organ Preservation Rate
Measured: an expected average of 1.5 years
Overall Survival
The time from the date of randomization to the death caused by any cause
Measured: an expected average of 5 years
Adverse events (AEs)
Adverse events and surgical safety
Measured: an expected average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start26 May 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancersStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHI-ZHONG PAN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622771
- Sponsor's protocol ID
- B2026-229-01
- Status last verified
- Sep 2026
- First submitted
- 28 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07622771
- Acronym / sponsor ID
- B2026-229-01
- Conditions
- Rectal Cancers
- Keywords
- radiotherapy, immunotherapy, neoadjuvant therapy, rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 3 Jun 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.
To explore the efficacy and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCRT combined with Adalimumab and NALIRIFOX | Experimental | Combination Product: Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOXAdalimumab combined with NALIRIFOX for two cycles. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: Adalimumab combined with NALIRIFOX for six cycles |
| LCRT combined with Adalimumab and NALIRIFOX | Experimental | Combination Product: Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOXAdalimumab combined with NALIRIFOX for two cycles. Radiotherapy: Long-course chemoradiotherapy (LCRT) (50Gy/25F, during the same period, capecitabine was 825 mg/m2, twice a day, 5 days a week). Consolidation: Adalimumab combined with NALIRIFOX for six cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients or their family members agree to participate in the study and sign the informed consent form;
- Age 18-75 years, male or female;
- Locally advanced rectal adenocarcinoma confirmed by histopathology;
- Clinical stage cT3-4bN0M0 or cTxN+M0, with or without MRF positive, with or without EMVI positive, expected to R0 resection;
- without intestinal obstruction;
Key exclusion criteria (20 listed)
- With inguinal lymph node metastasis or lateral lymph node metastasis (lymph node diameter ≥7 mm, or lymph node morphology and MRI features consistent with typical metastatic lymph nodes);
- Arrhythmia requiring antiarrhythmic treatment (except beta-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure exceeding NYHA Class II;
- Severe hypertension poorly controlled with medication;
- History of HIV infection, or active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay);
- Active pulmonary tuberculosis (TB), currently receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening;
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 |
|---|---|---|
| Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOXShort course radiotherapy, 5 * 5Gy, once a day, 5Gy each time, for 5 days; Adalimumab 1200 mg , D1, q2w, 2 cycles before radiotherapy and 6 cycles after radiotherapy; NALIRIFOX: Oxaliplatin 85 mg/m2, D1; Liposomal irinotecan 60 mg/m2, D1; LV 200 mg/m2; 5-FU 2400 mg/m2, Infusion for 48 hours; Repeat every 2 weeks. 2 cycles before radiotherapy and 6 cycles after radiotherapy; | Combination product | SCRT combined with Adalimumab and NALIRIFOX |
| Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOXLong course chemoradiotherapy,50 Gy in 25 fractions, during the same period, capecitabine was 825 mg / m2, twice a day, 5 days a week; Adalimumab 1200 mg , D1, q2w, 2 cycles before radiotherapy and 6 cycles after radiotherapy; NALIRIFOX: Oxaliplatin 85 mg/m2, D1; Liposomal irinotecan 60 mg/m2, D1; LV 200 mg/m2; 5-FU 2400 mg/m2, Infusion for 48 hours; Repeat every 2 weeks. 2 cycles before radiotherapy and 6 cycles after radiotherapy; | Combination product | LCRT combined with Adalimumab and NALIRIFOX |
Primary outcome
CR rate
Time frame: up to 6 months
the number of patients with a pCR for those who underwent surgery and a cCR for those who underwent WW; The pCR was defined as the absence of any tumor cells from the primary tumor and lymph nodes in the specimen after radical surgery (ypT0N0) or the absence of any tumor cells in the lesion after local resection (ypT0).The cCR was defined as the absence of residual disease on DRE, MRI, and endoscopy.
6 secondary outcomes
Event-Free Survival(EFS) rate
Time frame: an expected average of 5 years
R0 resection rate
Time frame: an expected average of 2 years
ORR[Objective Response Rate]
Time frame: an expected average of 1.5 years
OPR
Time frame: an expected average of 1.5 years
Overall Survival
Time frame: an expected average of 5 years
Adverse events (AEs)
Time frame: an expected average of 1.5 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 17 Sep 2026.
- Individual participant dataSharing planned: Yes
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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 Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX and Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX in people with Rectal Cancers, run by Sun Yat-sen 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 10 inclusion and 20 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 17 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 Chi Zhou (+86 20 87343920, 447486353@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR rate (time frame: up to 6 months). 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 17 Sep 2026.