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New treatment option for Rectal Cancer
Official title Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT07528209
What this study is testing
What is Pucotenlimab combine with CAPOX?
Pucotenlimab combine with CAPOX is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for rectal cancer.
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
- This is a multicenter, phase III, randomized controlled trial. Eligible patients with pMMR/MSS locally advanced rectal cancer will be randomized in a 1:1 ratio to either the experimental group or the control group using stratified randomization, with mesorectal fascia (MRF) status as the stratification factor.
- Phase 3: a large, late-stage study
- 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
- Age 18 to 75 years.
- Histologically confirmed rectal adenocarcinoma.
- The lower edge of the tumor is ≤12 cm from the anal verge.
- Clinical stage of cT3-4aN0M0 or cT1-4aN+M0 at initial diagnosis. Pre-treatment staging methods: Required: chest and abdominal CT and pelvic MRI...
- pMMR status confirmed by immunohistochemistry on colonoscopic biopsy specimens at the pathology department of the study center, or MSS/MSI-L status...
You likely can't join if
- Patients meeting any of the following criteria will be excluded:
- Clinical stage T4b disease.
- Positive lateral pelvic lymph nodes. Positive lateral pelvic lymph nodes are defined as either:
- a short-axis diameter ≥7 mm, or
- a short-axis diameter \<7 mm with at least two malignant imaging features, such as heterogeneous signal intensity, irregular shape, or spiculated...
- Predicted inability to preserve the anus. This is defined as tumor involvement of the dentate line and assessment by two senior colorectal surgeons...
See the full eligibility criteria
Who can join
- Age 18 to 75 years.
- Histologically confirmed rectal adenocarcinoma.
- The lower edge of the tumor is ≤12 cm from the anal verge.
- Clinical stage of cT3-4aN0M0 or cT1-4aN+M0 at initial diagnosis. Pre-treatment staging methods: Required: chest and abdominal CT and pelvic MRI. Optional: endorectal ultrasound or transrectal ultrasonography. For...
- pMMR status confirmed by immunohistochemistry on colonoscopic biopsy specimens at the pathology department of the study center, or MSS/MSI-L status confirmed by genetic testing (PCR-based or NGS-based methods).
- ECOG performance status 0-1.
- Voluntary participation in the study with written informed consent provided.
- No prior antitumor treatment for rectal adenocarcinoma, including but not limited to radiotherapy, chemotherapy, or surgery.
- Expected survival of at least 6 months.
- Adequate organ and bone marrow function, as defined below:
- Hematologic function No blood transfusion, hematopoietic growth factors, leukocyte-elevating agents, platelet-elevating agents, or anti-anemia therapy are allowed within 14 days before the first dose of study treatment...
- Biochemical function Serum albumin ≥30 g/L Total bilirubin ≤1.5 × upper limit of normal (ULN) ALT ≤2.5 × ULN AST ≤2.5 × ULN Alkaline phosphatase (ALP) ≤2.5 × ULN Serum creatinine ≤1.5 × ULN, or creatinine clearance...
- For women of childbearing potential, a serum or urine pregnancy test must be performed within 72 hours before the start of study treatment, with a negative result. Such patients must agree to use effective contraception...
- Good compliance and willingness to cooperate with study follow-up.
- Agreement to provide blood, urine, stool, and tumor tissue samples.
What rules you out
- Patients meeting any of the following criteria will be excluded:
- Clinical stage T4b disease.
- Positive lateral pelvic lymph nodes. Positive lateral pelvic lymph nodes are defined as either:
- a short-axis diameter ≥7 mm, or
- a short-axis diameter \<7 mm with at least two malignant imaging features, such as heterogeneous signal intensity, irregular shape, or spiculated margins.
- Predicted inability to preserve the anus. This is defined as tumor involvement of the dentate line and assessment by two senior colorectal surgeons that sphincter preservation is not feasible.
- Active autoimmune disease requiring systemic treatment within 2 years before enrollment, including but not limited to myasthenia gravis, systemic lupus erythematosus, interstitial pneumonitis, uveitis, ulcerative...
- Use of systemic corticosteroids within 14 days before the first dose of study treatment at a dose ≥10 mg/day prednisone equivalent, or use of other immunosuppressive agents, including but not limited to cyclosporine...
- Receipt of a live vaccine or attenuated live vaccine within 30 days before the first dose, or planned vaccination with such vaccines during the study period.
- Broad-spectrum antibiotic therapy by any route within 30 days before the first dose.
- Prior antitumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery (except biopsy), PD-1/CTLA-4 dual immunotherapy, regorafenib, or any other tyrosine kinase inhibitor.
- Presence of unresectable disease, including tumor-related unresectability, unresectability due to surgical contraindications, or refusal to undergo surgery.
- HIV infection, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation or allogeneic bone marrow transplantation (except corneal transplantation).
- Active viral hepatitis meeting any of the following criteria: hepatitis B surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive with HBV DNA \>10\^4 copies/mL (approximately 2000 IU/mL)...
- History of other malignancies within the past 5 years or concurrent malignancy, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage.
- Known active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or other diseases, symptoms, or signs indicating severely impaired pulmonary function.
- Renal failure requiring hemodialysis or peritoneal dialysis.
- Active infection, unexplained fever ≥38.5°C within 7 days before treatment, or baseline white blood cell count \>15 × 10\^9/L.
- Uncontrolled clinically significant cardiac disease, including but not limited to: New York Heart Association (NYHA) class II or above heart failure left ventricular ejection fraction (LVEF) \ 450 ms in males or \>470...
- Hypertension not adequately controlled with antihypertensive treatment, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg. Patients whose blood pressure can be controlled to below these...
- Arterial or venous thrombotic events within 6 months before enrollment, including cerebrovascular accident, transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep venous thrombosis, or pulmonary...
- Known hereditary or acquired bleeding or thrombotic disorders, such as hemophilia or coagulation dysfunction.
- Tumor invasion of major blood vessels, or imaging findings suggesting a high likelihood of major vascular invasion during the study period that may result in fatal hemorrhage, as judged by the investigator.
- Major surgery (excluding diagnostic procedures) within 4 weeks before the start of study treatment, or an anticipated need for major surgery during the study period other than protocol-specified surgery.
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months before the start of study treatment.
- Need for long-term or high-dose nonsteroidal anti-inflammatory drugs (for example, aspirin ≥325 mg/day) or anticoagulant therapy.
- Known or suspected allergy to the study drugs or to any medications administered in relation to this trial.
- History of severe hypersensitivity reactions to other monoclonal antibodies, or known allergy or hypersensitivity to PD-1 antibodies, oxaliplatin, capecitabine, or any of their components.
- Difficulty swallowing or inability to take oral study medication.
- Pregnant or breastfeeding women.
- Any other condition that, in the investigator's judgment, may interfere with study participation, affect study results, increase patient risk, or lead to premature termination of the study, including but not limited to...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Guangzhou, Guangdong, 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.