Rectal CancerPhase 2NCT07284992
SCRT VS LCRT Followed by PD-L1 Inhibitor Plus CAPEOX as TNT in Patients With LARC
A Phase 2 study testing short-term radiotherapy combined with Adebrelimab and capox and long-term radiotherapy combined with Adebrelimab and capox in people with Rectal Cancer and Advanced Stage Colorectal Cancer, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
This is a multicenter, cohort, prospective study to evaluate the efficacy and safety of Adebrelimab combined with radiotherapy and chemotherapy as preoperative neoadjuvant therapy for patients with locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Advanced Stage Colorectal Cancer, Radiotherapy
- What is being tested?
- short-term radiotherapy combined with Adebrelimab and capox and long-term radiotherapy combined with Adebrelimab and capox
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2025to 30 Jun 2033
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. sign written informed consent before implementing any test related process;
- 2. Patients diagnosed as rectal adenocarcinoma by primary biopsy and histopathological examination;
- 3. patients with CT stage ≥ T3 or CN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (>5mm) who are judged by imaging and colonoscopy to be operable and need neoadjuvant therapy.
- 4. according to imaging and colonoscopy, the main body of the tumor was located ≤ 10cm from the anal edge;
- 5. patients with tumor mismatch repair/microsatellite instability (MMR/MSI) status as MSS;
- 6. according to the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1), at least one lesion can be measured by imaging;
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- 7. the patient has not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc;
- 8. ECoG score: 0-1;
- 9. sufficient organ function, the subject shall meet the following laboratory indicators:
- The absolute value of neutrophils (ANC) ≥ 1.5x109/l without granulocyte colony stimulating factor in the past 14 days.
- Platelets ≥ 100 × 109/l without blood transfusion in recent 14 days.
- Hemoglobin>9g/dl without blood transfusion or use of erythropoietin in recent 14 days;
- Total bilirubin ≤ 1.5 × upper limit of normal value (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in ≤ 2.5 × ULN
- Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by Cockcroft Gault formula) ≥ 60 ml/min;
- Good coagulation function was defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
- Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
- Myocardial enzyme spectrum is within the normal range (for example, simple laboratory abnormalities that are not clinically significant according to the comprehensive judgment of the researcher are also allowed to be included in the group)
- 10. female subjects of childbearing age should receive urine or serum pregnancy test within 3 days before receiving the first study drug administration (the first day of the first cycle) and the result is negative. If the result of urine pregnancy test cannot be confirmed as negative, blood pregnancy test is required. Women of non reproductive age were defined as having been postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy; If there is a risk of pregnancy, all subjects (male or female) need to take contraceptive measures with an annual failure rate of less than 1% during the whole treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Who cannot join
- 1. patients diagnosed with other malignant tumors and not cured within 5 years before the first administration (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or cancer in situ after radical resection);
- 2. Patients with advanced rectal cancer with distant metastasis;
- 3. currently participating in intervention clinical research treatment, or having received other research drugs or used research instruments within 4 weeks before the first administration;
- 4. have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
- 5. have received systemic treatment with Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effect within 2 weeks before the first administration;
- 6. active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered as systemic therapy;
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- 7. the patients were receiving systemic glucocorticoid therapy (excluding local glucocorticoids via nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 14 days before the first administration of the study; Note: it is allowed to use physiological doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent drugs); In the absence of active autoimmune diseases, inhaled or topical steroid and prednisone dose>10mg/day or equivalent dose of adrenocortical hormone are allowed to replace;
- 8. known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- 9. those who are known to be allergic to the study drug adebaylimab and the active ingredients or excipients of combined chemotherapy drugs;
- 10. have not fully recovered from the toxicity and/or complications caused by any intervention measures before starting treatment (i.e. ≤ grade 1 or reaching the baseline, excluding fatigue or hair loss);
- 11. known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
- 12. untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center);
- Note: hepatitis B subjects who meet the following criteria can also be enrolled:
- HBV viral load<1000 copies/ml (200 iu/ml) before the first administration. Subjects should receive anti HBV treatment during the whole study chemotherapy drug treatment to avoid virus reactivation
- For subjects with anti HBC (+), HBsAg (-), anti HBS (-) and HBV viral load (-), preventive anti HBV treatment is not required, but virus reactivation needs to be closely monitored
- 13. active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit);
- 14. inoculate live vaccine within 30 days before the first administration (cycle 1, day 1); Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccines administered intranasal are not allowed.
- 15. pregnant or lactating women;
- 16. there are any serious or uncontrollable systemic diseases, such as:
- 1) The resting ECG has significant abnormalities in rhythm, conduction or morphology, and the symptoms are serious and difficult to control, such as complete left bundle branch block, heart block above grade II, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, chronic heart failure with NYHA classification ≥ 2; 3) Myocardial infarction occurred within 6 months before enrollment; 4) Blood pressure control was not ideal (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); 5) There was a history of non infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there was currently clinically active interstitial lung disease; 6) Active pulmonary tuberculosis; 7) Active or uncontrolled infection requiring systemic treatment; 8) There were clinically active diverticulitis, abdominal abscess and gastrointestinal obstruction; 9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10) Poor control of diabetes mellitus (FBG>10mmol/L); 11) The urine routine showed that the urine protein was ≥++, and it was confirmed that the 24-hour urine protein quantitation was more than 1.0 G; 12) Patients with mental disorders and unable to cooperate with treatment;
- 17. for those who have a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the clinical severity may hinder the signing of informed consent or affect the patient's compliance with oral drugs according to the judgment of the investigator; The medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subjects from participating in the whole process of the study, or the researchers believe that there are other potential risks that are not suitable for the study.
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
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021
Feng Tian Associate Professor, +8618866102886, tianfeng@sdu.edu.cn
About this study
Official title: Total Neoadjuvant Treatment With Short-course Radiotherapy Versus Long-course Radiotherapy Followed by PD-L1 Inhibitor Plus Capecitabine-Oxaliplatin in Patients With Locally Advanced Rectal Cancer: a Multi-centres, Open-label, Phase 2, Randomized Controlled Trial
This is a multicenter, cohort, prospective study to evaluate the efficacy and safety of Adebrelimab combined with radiotherapy and chemotherapy as preoperative neoadjuvant therapy for patients with locally advanced rectal cancer. In the study, all subjects who meet the inclusion criteria will enter the short-term radiotherapy queue and the long-term radiotherapy queue at the ratio of 1:1. The short-term radiotherapy queue plans to receive Adebrelimab combined with short-term radiotherapy (5*5Gy) and Capox chemotherapy as neoadjuvant therapy. The long-term radiotherapy queue plans to receive Adebrelimab combined with long-term radiotherapy (1.8gy × 25-28 times) and capox chemotherapy as neoadjuvant therapy. The TME surgery will be performed 2-3 weeks after the last neoadjuvant therapy is completed. If the surgery cannot be performed within the time window specified in the plan (such as delayed adverse reactions, etc.), the researcher will conduct the surgery according to the patients' requirements.The actual clinical conditions of the subjects were comprehensively considered.
- Being tested
- short-term radiotherapy combined with Adebrelimab and capox, long-term radiotherapy combined with Adebrelimab and capox
- Keywords
- Immune checkpoint inhibitors, Adebrelimab Injection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short-term radiotherapy combined with Adebrelimab and capoxCombination product
Also called Adebrelimab, CAPOX
Radiotherapy protocol: 5 × 5Gy short-term radiotherapy (D1-5 in the first week) Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle.
Chemotherapy regimen: capox regimen:
Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ～ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme.
long-term radiotherapy combined with Adebrelimab and capoxCombination product
Also called Adebrelimab, CAPOX
Radiotherapy regimen: long-term radiotherapy 1.8 × 25-28Gy, oral capecitabine in the same period: the standard dose is 825mg/m2, twice a day [total dose 1650mg/(M2 · d)], oral radiotherapy day, 5 days a week.
Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle.
Chemotherapy regimen: capox regimen:
Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ～ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Radiotherapy protocol: 5 × 5Gy short-term radiotherapy (D1-5 in the first week) Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle.
Chemotherapy regimen: capox regimen:
Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ～ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme. Receives: Combination Product: short-term radiotherapy combined with Adebrelimab and capox |
| Group 2 | Experimental | Radiotherapy regimen: long-term radiotherapy 1.8 × 25-28Gy, oral capecitabine in the same period: the standard dose is 825mg/m2, twice a day [total dose 1650mg/(M2 · d)], oral radiotherapy day, 5 days a week.
Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle.
Chemotherapy regimen: capox regimen:
Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ～ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme. Receives: Combination Product: long-term radiotherapy combined with Adebrelimab and capox |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate
pathological complete remission rate (PCR) and clinical complete remission rate (CCR)
Measured: From enrollment to the end of surgery,assessed up to 6 months
Secondary outcomes (6)
partial remission rate (PR)
the total diameter of all measurable target lesions is ≥ 30% lower than the baseline
Measured: The evaluation time from enrollment to the first efficacy evaluation is up to 3 months
Objective response rate (ORR)
Proportion of subjects defined as complete remission (CR) and partial remission (PR) in total subjects
Measured: The evaluation time from enrollment to the first efficacy evaluation is up to 3 months
Major Pathological Response Rate (MPR)
Major Pathological Response Rate (MPR)
Measured: From enrollment to the end of surgery,assessed up to 6 months
R0 resection rate
There is no visible tumor residue in the body, and no residual tumor cells are found under the pathological microscope
Measured: From enrollment to the end of surgery,assessed up to 6 months
2-year DFS rate
2-year progression free survival rate
Measured: The longest follow-up time was 2 years from enrollment to disease progression
3-year OS rate
3-year OS rate
Measured: The longest follow-up time was 3 years from enrollment to death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start12 Sep 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Feng Tian, Shandong Provincial Hospital
- Investigators
- Changqing Jing, Professor, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284992
- Sponsor's protocol ID
- SPRING03
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Neoadjuvant Treatment With Short-course Radiotherapy Versus Long-course Radiotherapy Followed by PD-L1 Inhibitor Plus Capecitabine-Oxaliplatin in Patients With Locally Advanced Rectal Cancer: a Multi-centres, Open-label, Phase 2, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07284992
- Acronym / sponsor ID
- SPRING03
- Keywords
- Immune checkpoint inhibitors, Adebrelimab Injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 16 Dec 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.
This is a multicenter, cohort, prospective study to evaluate the efficacy and safety of Adebrelimab combined with radiotherapy and chemotherapy as preoperative neoadjuvant therapy for patients with locally advanced rectal cancer. In the study, all subjects who meet the inclusion criteria will enter the short-term radiotherapy queue and the long-term radiotherapy queue at the ratio of 1:1. The short-term radiotherapy queue plans to receive Adebrelimab combined with short-term radiotherapy (5*5Gy) and Capox chemotherapy as neoadjuvant therapy. The long-term radiotherapy queue plans to receive Adebrelimab combined with long-term radiotherapy (1.8gy × 25-28 times) and capox chemotherapy as neoadjuvant therapy. The TME surgery will be performed 2-3 weeks after the last neoadjuvant therapy is completed. If the surgery cannot be performed within the time window specified in the plan (such as delayed adverse reactions, etc.), the researcher will conduct the surgery according to the patients' requirements.The actual clinical conditions of the subjects were comprehensively considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Combination Product: short-term radiotherapy combined with Adebrelimab and capoxRadiotherapy protocol: 5 × 5Gy short-term radiotherapy (D1-5 in the first week) Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle. Chemotherapy regimen: capox regimen: Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ～ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme. |
| Group 2 | Experimental | Combination Product: long-term radiotherapy combined with Adebrelimab and capoxRadiotherapy regimen: long-term radiotherapy 1.8 × 25-28Gy, oral capecitabine in the same period: the standard dose is 825mg/m2, twice a day [total dose 1650mg/(M2 · d)], oral radiotherapy day, 5 days a week. Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle. Chemotherapy regimen: capox regimen: Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ～ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 1. sign written informed consent before implementing any test related process;
- 2. Patients diagnosed as rectal adenocarcinoma by primary biopsy and histopathological examination;
- 3. patients with CT stage ≥ T3 or CN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (>5mm) who are judged by imaging and colonoscopy to be operable and need neoadjuvant therapy.
- 4. according to imaging and colonoscopy, the main body of the tumor was located ≤ 10cm from the anal edge;
- 5. patients with tumor mismatch repair/microsatellite instability (MMR/MSI) status as MSS;
Key exclusion criteria (21 listed)
- 1. patients diagnosed with other malignant tumors and not cured within 5 years before the first administration (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or cancer in situ after radical resection);
- 2. Patients with advanced rectal cancer with distant metastasis;
- 3. currently participating in intervention clinical research treatment, or having received other research drugs or used research instruments within 4 weeks before the first administration;
- 4. have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
- 5. have received systemic treatment with Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effect within 2 weeks before the first administration;
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-term radiotherapy combined with Adebrelimab and capoxAlso: Adebrelimab, CAPOXRadiotherapy protocol: 5 × 5Gy short-term radiotherapy (D1-5 in the first week) Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle. Chemotherapy regimen: capox regimen: Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ～ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme. | Combination product | Group 1 |
| long-term radiotherapy combined with Adebrelimab and capoxAlso: Adebrelimab, CAPOXRadiotherapy regimen: long-term radiotherapy 1.8 × 25-28Gy, oral capecitabine in the same period: the standard dose is 825mg/m2, twice a day [total dose 1650mg/(M2 · d)], oral radiotherapy day, 5 days a week. Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle. Chemotherapy regimen: capox regimen: Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ～ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme. | Combination product | Group 2 |
Primary outcome
CR rate
Time frame: From enrollment to the end of surgery,assessed up to 6 months
pathological complete remission rate (PCR) and clinical complete remission rate (CCR)
6 secondary outcomes
partial remission rate (PR)
Time frame: The evaluation time from enrollment to the first efficacy evaluation is up to 3 months
Objective response rate (ORR)
Time frame: The evaluation time from enrollment to the first efficacy evaluation is up to 3 months
Major Pathological Response Rate (MPR)
Time frame: From enrollment to the end of surgery,assessed up to 6 months
R0 resection rate
Time frame: From enrollment to the end of surgery,assessed up to 6 months
2-year DFS rate
Time frame: The longest follow-up time was 2 years from enrollment to disease progression
3-year OS rate
Time frame: The longest follow-up time was 3 years from enrollment to death from any cause
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 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Changqing Jing, Professor principal investigator
Shandong Provincial Hospital
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 short-term radiotherapy combined with Adebrelimab and capox and long-term radiotherapy combined with Adebrelimab and capox in people with Rectal Cancer and Advanced Stage Colorectal Cancer, run by Shandong Provincial 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 19 inclusion and 21 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 16 Dec 2025. 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 Feng Tian, Dr. (+86 18866102886, tianfeng@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR rate (time frame: From enrollment to the end of surgery,assessed 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 16 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.