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New treatment option for Locally Advanced Rectal Cancer (LARC)
Official title SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT06864013
What this study is testing
What is Experimental?
Experimental is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced rectal cancer (larc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Patients with microsatellite stability (MSS) or proficient mismatch repair (pMMR) rectal cancer
You likely can't join if
- 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...
- Simultaneous participation in another clinical study, unless participating in an observational (non-treatment) clinical study or in the survival...
- 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)...
- Use of immunosuppressive drugs within 4 weeks prior to the first dose of the study drug, excluding: intranasal inhaled local steroid therapy or local...
See the full eligibility criteria
Who can 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
- 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...
- 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...
- No serious concomitant diseases that threaten the subject's survival (resulting in an expected survival time of less than 5 years)
- Female people of childbearing potential or male people with partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after the treatment period. Female people...
What rules you out
- 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...
- Simultaneous participation in another clinical study, unless participating in an observational (non-treatment) clinical study or in the survival follow-up phase of an treatment 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...
- 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...
- 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...
- Known active or suspected autoimmune disease or history of autoimmune disease within the past 2 years (people with eczema, vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment in the past 2...
- 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...
- 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...
- Symptomatic congestive heart failure (New York Heart Association class II\~IV) or left ventricular ejection fraction (LVEF) \ 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...
- 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...
- 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; people at risk of intestinal perforation (including but not limited to acute...
- Interstitial lung disease requiring treatment; history and current presence of pulmonary fibrosis, pneumoconiosis, drug-related pneumonia, organic pneumonia (such as bronchiolitis obliterans), severe pulmonary...
- 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...
- 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...
- 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...
- Alcohol, drug, or substance use that may hinder drug administration or affect toxicity analysis
- Pregnant or breastfeeding female people
- Other situations deemed unsuitable for enrollment by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.