Locally Advanced Rectal Cancer (LARC)Phase 2NCT06864013
SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer
A Phase 2 study testing Experimental in people with Locally Advanced Rectal Cancer (LARC), run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Colorectal cancer ranks as the third most prevalent malignancy worldwide and the second leading cause of cancer-related mortality. For patients with locally advanced rectal cancer (LARC) classified as T3-4/N+ without distant metastasis, achieving organ preservation and functional integrity while pursuing curative… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- What is being tested?
- Experimental
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2025to 31 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
- Sign a written Informed Consent Form (ICF) and be able to comply with the visits and related procedures stipulated in the protocol
- Age between 18 and 75 years old
- Histologically confirmed rectal adenocarcinoma
- According to the AJCC 8th Edition staging, imaging evaluation (enhanced CT or enhanced MRI) confirms resectable locally advanced rectal cancer (AJCC 8th Edition staging cT3-4 / cN+)
- Patients with microsatellite stability (MSS) or proficient mismatch repair (pMMR) rectal cancer
- At least one evaluable lesion according to RECIST v1.1 criteria
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- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1
- Adequate organ and bone marrow function, defined as follows:
- Blood count: Absolute Neutrophil Count (ANC) ≥1.5×10^9/L; Platelet (PLT) ≥100×10^9/L; Hemoglobin (HGB) ≥10.0 g/dL.
- Liver function: Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal (ULN); Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤3×ULN. Serum albumin (ALB) ≥35 g/L.
- Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml/min (calculated using the Cockcroft-Gault formula or standard 24-hour urine collection method); Urine dipstick test shows urine protein <2+; For subjects with baseline urine dipstick test showing urine protein ≥2+, a 24-hour urine collection should be performed, and the protein content in the 24-hour urine should be <1 g.
- Coagulation function: International Normalized Ratio (INR) ≤1.5, and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN. Certain anticoagulant drugs (such as antiplatelet drugs, vitamin K antagonists, etc.) need to be discontinued 7~14 days before surgery and replaced with other drugs (such as low molecular weight heparin)
- No serious concomitant diseases that threaten the subject's survival (resulting in an expected survival time of less than 5 years)
- Female subjects of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after the treatment period. Female subjects must have evidence of postmenopausal status or a negative urine or serum pregnancy test result for premenopausal female subjects.
Who cannot join
- Patients with rectal cancer who have been tested for microsatellite instability as MSI-H or mismatch repair as dMMR
- Patients who have previously received any anti-tumor treatment for the studied disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. This includes previous treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) drugs, or any other drugs acting on T cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.), as well as adoptive cell immunotherapy
- Simultaneous participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study
- Treatment with any investigational drug or device within 4 weeks prior to the first dose of the study drug
- History of blood transfusion within 14 days before the screening laboratory tests, or use of Granulocyte-colony stimulating factor (G-CSF), Granulocyte-Macrophage-colony stimulating factor (GM-CSF), erythropoietin (EPO), thrombopoietin (TPO), or IL-11
- Use of immunosuppressive drugs within 4 weeks prior to the first dose of the study drug, excluding: intranasal inhaled local steroid therapy or local steroid injections (such as intra-articular injections); systemic corticosteroid therapy not exceeding 10 mg/day of prednisone or its equivalent physiological dose; glucocorticoids as preventive medication for allergic reactions (such as pre-CT medication); use of Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications (including thymosin, interferon, interleukin, etc.) within 1 week prior to the first dose of the study drug
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- Receipt of live or attenuated live vaccines within 4 weeks prior to the first dose of the study drug or expected during the study period
- Major surgical procedures (such as craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of the study drug, anticipated need for major surgery during the study treatment period (except for radical rectal cancer surgery as specified in the protocol), or presence of unhealed wounds, ulcers, or fractures
- Known active or suspected autoimmune disease or history of autoimmune disease within the past 2 years (subjects with eczema, vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment in the past 2 years, history of hypothyroidism requiring only thyroid hormone replacement therapy or autoimmune hypothyroidism, and type I diabetes requiring only insulin replacement therapy may be enrolled)
- Known history of primary immunodeficiency
- Active tuberculosis, currently receiving anti-tuberculosis treatment or having received anti-tuberculosis treatment within 1 year prior to the first dose of the study drug
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Known allergy to capecitabine, oxaliplatin, anti-PD-1 monoclonal antibody, anti-CTLA-1 monoclonal antibody, anti-PD-1/CTLA-4 antibody preparation, or other monoclonal antibody components
- Ascites and pleural effusion requiring clinical intervention in the short term, symptomatic or requiring drainage of pericardial effusion
- Human immunodeficiency virus (HIV) infection (HIV antibody positive)
- Acute or chronic active hepatitis B (defined as HBsAg or only HBcAb positive and HBV DNA ≥2000 IU/mL or ≥1×10^4 copies/mL), acute or chronic active hepatitis C (defined as HCV antibody positive and HCV-RNA level above the lower limit of detection)
- HBV DNA ≥2000 IU/mL or ≥1×10^4 copies/mL), acute or chronic active hepatitis C (defined as HCV antibody positive and HCV-RNA level above the lower limit of detection)
- Active syphilis infection requiring treatment
- Severe infection occurring within 4 weeks prior to the first dose of the study drug or during the active phase or poorly controlled, including but not limited to hospitalization for infection, bacteremia, or complications of severe pneumonia, therapeutic oral or intravenous antibiotics within two weeks prior to the first dose
- Symptomatic congestive heart failure (New York Heart Association class II~IV) or left ventricular ejection fraction (LVEF) <50% on echocardiography; symptomatic or poorly controlled arrhythmia; history of congenital long QT syndrome or corrected QTc >500 ms at screening (calculated using Fridericia's method)
- Uncontrolled arterial hypertension despite standard treatment (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), history of hypertensive crisis or hypertensive encephalopathy
- Severe bleeding tendency or coagulation dysfunction, or undergoing thrombolytic therapy
- Any arterial thromboembolic event within 6 months prior to the first dose of the study drug, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack
- Esophageal or gastric varices requiring immediate intervention (e.g., ligation or sclerotherapy) or considered at high risk of bleeding by the investigator or after consultation with a gastroenterologist or hepatologist, evidence of portal hypertension (including splenomegaly on imaging) or history of variceal bleeding, subjects must undergo endoscopic evaluation within 3 months prior to enrollment
- History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the study drug
- Any life-threatening bleeding event within 3 months prior to the first dose of the study drug, or grade 3 or 4 gastrointestinal/variceal bleeding event requiring transfusion, endoscopy, or surgical treatment
- History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 3 months prior to the first dose of the study drug (implantable venous port or catheter-related thrombosis, or superficial venous thrombosis is not considered "severe" thromboembolism)
- Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or cancer-related reactions that may lead to higher medical risks and/or uncertainty in survival evaluation
- Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B >7 points or more severe cirrhosis
- Intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition) and not relieved by the screening period; subjects at risk of intestinal perforation (including but not limited to acute diverticulitis, abdominal abscess, history of abdominal cancer); history of extensive intestinal resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea
- Interstitial lung disease requiring treatment; history and current presence of pulmonary fibrosis, pneumoconiosis, drug-related pneumonia, organic pneumonia (such as bronchiolitis obliterans), severe pulmonary impairment, etc.
- Significant malnutrition (weight loss of 5% within 1 month or 15% within 3 months prior to signing the informed consent, or reduction in food intake by 1/2 or more within 1 week), or patients requiring intravenous nutritional support. However, malnutrition corrected more than 4 weeks prior to the first dose of the study drug is excluded
- History of other primary malignancies, except: malignancies that have been cured, with no known active disease for ≥2 years prior to the first dose of the study drug and with a very low risk of recurrence
- Adequately treated non-melanoma skin cancer or malignant lentigo with no evidence of disease recurrence
- Adequately treated carcinoma in situ with no evidence of disease recurrence
- Other acute or chronic diseases that may result in: increased risk related to study participation or study drug administration, or interference with the interpretation of study results, and in the investigator's judgment, render the subject ineligible for participation in this study
- Neurological, psychiatric disorders, or social conditions that: affect compliance with study requirements, significantly increase the risk of adverse events, or affect the subject's ability to provide written informed consent, such as history of schizophrenia, drug abuse, etc.
- Alcohol, drug, or substance use that may hinder drug administration or affect toxicity analysis
- Pregnant or breastfeeding female subjects
- Other situations deemed unsuitable for enrollment by the investigator
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
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Guosheng Wu, MD, +8617857310313 ext. 87236858, guosheng_wu@zju.edu.cn
About this study
Official title: Short-course Neoadjuvant Radiotherapy Combined With Chemotherapy and Iparomlimab and Tuvonralimab in Microsatellite Stability (MSS) or Mismatch-repair-proficient (pMMR) Patients With Locally Advanced Rectal Cancer: A Randomized Controlled Clinical Study
Colorectal cancer ranks as the third most prevalent malignancy worldwide and the second leading cause of cancer-related mortality. For patients with locally advanced rectal cancer (LARC) classified as T3-4/N+ without distant metastasis, achieving organ preservation and functional integrity while pursuing curative treatment remains a formidable clinical challenge. This study aims to evaluate the efficacy and organ preservation rates of a novel neoadjuvant regimen comprising short-course radiotherapy followed by four cycles of CAPEOX combined with Iparomlimab and Tuvonralimab in patients with microsatellite stable (MSS) or mismatch repair proficient (pMMR) LARC. Furthermore, the project will investigate potential predictive biomarkers for complete response (CR) within this immunotherapy-based total neoadjuvant therapy (iTNT) paradigm.
Read the detailed description
This study adopts a prospective, multicenter research design. It aims to evaluate the effectiveness and organ preservation rate of neoadjuvant short-course radiotherapy followed by 4 cycles of CAPEOX + Iparomlimab and Tuvonralimab in patients with MSS or pMMR LARC (AJCC eighth edition stage cT3-4 / cN+) who are initially diagnosed and can be surgically resected and randomized to the experimental group (SCRT followed by 4 cycles of CAPEOX combined with Iparomlimab and Tuvonralimab) and the control group (SCRT followed by 4 cycles of CAPEOX).
The experimental group will receive neoadjuvant short-course radiotherapy, followed by CAPEOX+Iparomlimab and Tuvonralimab for 4 cycles. The control group will receive neoadjuvant short-course radiotherapy,followed by CAPEOX for 4 cycles. During or after the completion of neoadjuvant therapy, if the patients cannot undergo radical surgical resection due to disease progression (based on RECIST v1.1) or other reasons, the treatment of this study will be terminated.
For patients who are evaluated as clinical complete remission (cCR) by imaging, colonoscopy, and pathology, the watch and wait (W\&W) indications or surgical methods will be discussed by multidisciplinary team (MDT). Among them, patients with cCR or near clinical complete remission (ncCR) in efficacy evaluation will receive W\&W or transanal endoscopic surgery (TES) to preserve organ function, and patients with non-cCR/ncCR will undergo total mesorectal excision (TME). After surgery, patients in the experimental group will receive CAPEOX combined with Iparomlimab and Tuvonralimab for 4 cycles, followed by sequential treatment with Iparomlimab and Tuvonralimab for up to 1 year. Patients in the control group will receive CAPEOX for 4 cycles until the planned course of treatment is completed or the disease relapses, intolerable toxicity occurs, informed consent is withdrawn, lost to follow-up or death, or other circumstances that require treatment discontinuation (whichever occurs first).
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Being tested
- Experimental, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDrug
The experimental group will receive neoadjuvant short-course radiotherapy (dose 25Gy/5f), followed by CAPEOX+Iparomlimab and Tuvonralimab (capecitabine 1000mg/m2 bid po d1-d14, q3w; oxaliplatin 130mg/m2 iv d1, q3w; Iparomlimab and Tuvonralimab 5mg/kg iv d1, q3w) for 4 cycles. Patients who undergo surgery will receive CAPEOX combined with Iparomlimab and Tuvonralimab for 4 cycles, followed by sequential treatment with Iparomlimab and Tuvonralimab for up to 1 year.
ControlDrug
The control group will receive neoadjuvant short-course radiotherapy,followed by CAPEOX (capecitabine 1000mg/m2 bid po d1-d14, q3w; oxaliplatin 130mg/m2 iv d1, q3w) for 4 cycles. Patients who undergo sugery will receive CAPEOX for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | The experimental group will receive neoadjuvant short-course radiotherapy, followed by CAPEOX+Iparomlimab and Tuvonralimab for 4 cycles. Patients who undergo surgery will receive CAPEOX combined with Iparomlimab and Tuvonralimab for 4 cycles, followed by sequential treatment with Iparomlimab and Tuvonralimab for up to 1 year. Receives: Drug: Experimental |
| Control Arm | Other | The control group will receive neoadjuvant short-course radiotherapy,followed by CAPEOX for 4 cycles. Patients who undergo sugery will receive CAPEOX for 4 cycles. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
Measured: From date of randomization until the date of treatment of surgery, assessed up to 5 months
Clinical Complete Response
Measured: From date of randomization until the date of discussion of multidisciplinary team, assessed up to 5 months
Pathologic Complete Response
Measured: From date of randomization until the date of treatment of surgery, assessed up to 5 months
Secondary outcomes (5)
Organ Preservation Rate
Measured: From date of randomization until the date of treatment of additional surgery, assessed up to 100 months
Major Pathologic Response
Measured: From date of randomization until the date of treatment of surgery, assessed up to 5 months
Overall Surviral
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Desease Free Survival
Measured: From date of randomization until the date of first documented progression, whichever came first, assessed up to 100 months
Anal Sphincter Preservation Rate
Measured: From date of randomization until the date of treatment of surgery, assessed up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start6 Jan 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 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 (LARC)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No.2 Hospital, Ningbo Medical Center Lihuili Hospital, Second Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, The Affiliated People's Hospital of Ningbo University, Taizhou Hospital
- Responsible party
- Sponsor
- Investigators
- Guosheng Wu, MD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864013
- Sponsor's protocol ID
- IIT20240172C
- Status last verified
- Jan 2026
- First submitted
- 20 Feb 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Neoadjuvant Radiotherapy Combined With Chemotherapy and Iparomlimab and Tuvonralimab in Microsatellite Stability (MSS) or Mismatch-repair-proficient (pMMR) Patients With Locally Advanced Rectal Cancer: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06864013
- Acronym / sponsor ID
- IIT20240172C
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Ningbo No.2 Hospital, Ningbo Medical Center Lihuili Hospital, Second Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, The Affiliated People's Hospital of Ningbo University, Taizhou Hospital
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Mar 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.
Colorectal cancer ranks as the third most prevalent malignancy worldwide and the second leading cause of cancer-related mortality. For patients with locally advanced rectal cancer (LARC) classified as T3-4/N+ without distant metastasis, achieving organ preservation and functional integrity while pursuing curative treatment remains a formidable clinical challenge. This study aims to evaluate the efficacy and organ preservation rates of a novel neoadjuvant regimen comprising short-course radiotherapy followed by four cycles of CAPEOX combined with Iparomlimab and Tuvonralimab in patients with microsatellite stable (MSS) or mismatch repair proficient (pMMR) LARC. Furthermore, the project will investigate potential predictive biomarkers for complete response (CR) within this immunotherapy-based total neoadjuvant therapy (iTNT) paradigm.
Detailed description
This study adopts a prospective, multicenter research design. It aims to evaluate the effectiveness and organ preservation rate of neoadjuvant short-course radiotherapy followed by 4 cycles of CAPEOX + Iparomlimab and Tuvonralimab in patients with MSS or pMMR LARC (AJCC eighth edition stage cT3-4 / cN+) who are initially diagnosed and can be surgically resected and randomized to the experimental group (SCRT followed by 4 cycles of CAPEOX combined with Iparomlimab and Tuvonralimab) and the control group (SCRT followed by 4 cycles of CAPEOX).
The experimental group will receive neoadjuvant short-course radiotherapy, followed by CAPEOX+Iparomlimab and Tuvonralimab for 4 cycles. The control group will receive neoadjuvant short-course radiotherapy,followed by CAPEOX for 4 cycles. During or after the completion of neoadjuvant therapy, if the patients cannot undergo radical surgical resection due to disease progression (based on RECIST v1.1) or other reasons, the treatment of this study will be terminated.
For patients who are evaluated as clinical complete remission (cCR) by imaging, colonoscopy, and pathology, the watch and wait (W\&W) indications or surgical methods will be discussed by multidisciplinary team (MDT). Among them, patients with cCR or near clinical complete remission (ncCR) in efficacy evaluation will receive W\&W or transanal endoscopic surgery (TES) to preserve organ function, and patients with non-cCR/ncCR will undergo total mesorectal excision (TME). After surgery, patients in the experimental group will receive CAPEOX combined with Iparomlimab and Tuvonralimab for 4 cycles, followed by sequential treatment with Iparomlimab and Tuvonralimab for up to 1 year. Patients in the control group will receive CAPEOX for 4 cycles until the planned course of treatment is completed or the disease relapses, intolerable toxicity occurs, informed consent is withdrawn, lost to follow-up or death, or other circumstances that require treatment discontinuation (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: ExperimentalThe experimental group will receive neoadjuvant short-course radiotherapy, followed by CAPEOX+Iparomlimab and Tuvonralimab for 4 cycles. Patients who undergo surgery will receive CAPEOX combined with Iparomlimab and Tuvonralimab for 4 cycles, followed by sequential treatment with Iparomlimab and Tuvonralimab for up to 1 year. |
| Control Arm | Other | Drug: ControlThe control group will receive neoadjuvant short-course radiotherapy,followed by CAPEOX for 4 cycles. Patients who undergo sugery will receive CAPEOX for 4 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Sign a written Informed Consent Form (ICF) and be able to comply with the visits and related procedures stipulated in the protocol
- Age between 18 and 75 years old
- Histologically confirmed rectal adenocarcinoma
- According to the AJCC 8th Edition staging, imaging evaluation (enhanced CT or enhanced MRI) confirms resectable locally advanced rectal cancer (AJCC 8th Edition staging cT3-4 / cN+)
- Patients with microsatellite stability (MSS) or proficient mismatch repair (pMMR) rectal cancer
Key exclusion criteria (40 listed)
- Patients with rectal cancer who have been tested for microsatellite instability as MSI-H or mismatch repair as dMMR
- Patients who have previously received any anti-tumor treatment for the studied disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. This includes previous treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) drugs, or any other drugs acting on T cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.), as well as adoptive cell immunotherapy
- Simultaneous participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study
- Treatment with any investigational drug or device within 4 weeks prior to the first dose of the study drug
- History of blood transfusion within 14 days before the screening laboratory tests, or use of Granulocyte-colony stimulating factor (G-CSF), Granulocyte-Macrophage-colony stimulating factor (GM-CSF), erythropoietin (EPO), thrombopoietin (TPO), or IL-11
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 |
|---|---|---|
| ExperimentalThe experimental group will receive neoadjuvant short-course radiotherapy (dose 25Gy/5f), followed by CAPEOX+Iparomlimab and Tuvonralimab (capecitabine 1000mg/m2 bid po d1-d14, q3w; oxaliplatin 130mg/m2 iv d1, q3w; Iparomlimab and Tuvonralimab 5mg/kg iv d1, q3w) for 4 cycles. Patients who undergo surgery will receive CAPEOX combined with Iparomlimab and Tuvonralimab for 4 cycles, followed by sequential treatment with Iparomlimab and Tuvonralimab for up to 1 year. | Drug | Experimental Arm |
| ControlThe control group will receive neoadjuvant short-course radiotherapy,followed by CAPEOX (capecitabine 1000mg/m2 bid po d1-d14, q3w; oxaliplatin 130mg/m2 iv d1, q3w) for 4 cycles. Patients who undergo sugery will receive CAPEOX for 4 cycles. | Drug | Control Arm |
Primary outcome
Complete Response
Time frame: From date of randomization until the date of treatment of surgery, assessed up to 5 months
Clinical Complete Response
Time frame: From date of randomization until the date of discussion of multidisciplinary team, assessed up to 5 months
Pathologic Complete Response
Time frame: From date of randomization until the date of treatment of surgery, assessed up to 5 months
5 secondary outcomes
Organ Preservation Rate
Time frame: From date of randomization until the date of treatment of additional surgery, assessed up to 100 months
Major Pathologic Response
Time frame: From date of randomization until the date of treatment of surgery, assessed up to 5 months
Overall Surviral
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Desease Free Survival
Time frame: From date of randomization until the date of first documented progression, whichever came first, assessed up to 100 months
Anal Sphincter Preservation Rate
Time frame: From date of randomization until the date of treatment of surgery, assessed up to 5 months
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 14 Jan 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.
Guosheng Wu, MD principal investigator
Zhejiang University
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 Experimental in people with Locally Advanced Rectal Cancer (LARC), run by First Affiliated Hospital of Zhejiang 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 14 inclusion and 40 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 14 Jan 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 Guosheng Wu, MD (+8617857310313 ext. 87236858, guosheng_wu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (time frame: From date of randomization until the date of treatment of surgery, assessed up to 5 months). The study lists 3 primary outcomes in all. 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 14 Jan 2026.