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Compares treatment options for Rectal Cancer
Official title SCRT VS LCRT Followed by PD-L1 Inhibitor Plus CAPEOX as TNT in Patients With LARC
ClinicalTrials.gov ID: NCT07284992
What this study is testing
What is short-term radiotherapy combined with Adebrelimab and capox?
short-term radiotherapy combined with Adebrelimab and capox is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rectal cancer.
Also referred to as Adebrelimab, CAPOX.
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, 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.
- Phase 2: a mid-size study of how well it works
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 80
You may be able to join if
- 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...
- 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;
You likely can't join if
- 1\. patients diagnosed with other malignant tumors and not cured within 5 years before the first administration (excluding skin basal cell carcinoma...
- 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\. 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...
- 5\. have received systemic treatment with Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effect within 2 weeks...
- 6\. active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants)...
See the full eligibility criteria
Who can 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 how well it works of solid tumors (RECIST version 1.1), at least one lesion can be measured by imaging;
- 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, people with total T3 (or FT3) and FT4 within the normal range can also be...
- 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...
- 10\. female people 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...
What rules you out
- 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...
- 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...
- 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...
- 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 people who meet...
- HBV viral load\<1000 copies/ml (200 iu/ml) before the first administration. people should receive anti HBV treatment during the whole study chemotherapy drug treatment to avoid virus reactivation
- For people 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 people (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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, 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.