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New treatment option for Rectal Cancer
Official title Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT06765616
What this study is testing
What is Adebrelimab Injection combined with radiotherapy and chemotherapy?
Adebrelimab Injection combined with radiotherapy and chemotherapy is an investigational medicine, given as an 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 study is a multicenter, single arm, prospective study aimed at evaluating the efficacy and safety of adebelimab combined with short course radiotherapy (5 \ 5Gy) and chemotherapy as preoperative neoadjuvant therapy for locally advanced rectal cancer patients. In the study, all subjects who met the inclusion criteria will receive a combination of adebelimab, short course radiotherapy (5 \ 5Gy), and CAPOX chemotherapy as neoadjuvant therapy according to the study plan.
- 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 85
You may be able to join if
- Sign written informed consent before implementing any experimental procedures;
- Male or female, aged 18 or above and 85 or below;
- Patients diagnosed with rectal adenocarcinoma through primary lesion biopsy and histopathological examination;
- Patients with cT stage ≥ T3 or cN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (\>5mm) who are determined to be...
- According to imaging and colonoscopy examination, the main body of the patient's tumor is located ≤ 15cm away from the anal edge;
You likely can't join if
- Patients diagnosed with other malignant tumors that have not been cured within 5 years before the first administration (excluding skin basal cell...
- Late stage rectal cancer patients with distant metastasis;
- Currently participating in treatment clinical research treatment, or having received other research drugs or used research instruments for treatment...
- 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...
- Have received systemic treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with...
- Within 2 years prior to the first administration, there has been an active autoimmune disease requiring systemic treatment (such as the use of...
See the full eligibility criteria
Who can join
- Sign written informed consent before implementing any experimental procedures;
- Male or female, aged 18 or above and 85 or below;
- Patients diagnosed with rectal adenocarcinoma through primary lesion biopsy and histopathological examination;
- Patients with cT stage ≥ T3 or cN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (\>5mm) who are determined to be operable and require neoadjuvant therapy through imaging and colonoscopy...
- According to imaging and colonoscopy examination, the main body of the patient's tumor is located ≤ 15cm away from the anal edge;
- According to the criteria for evaluating the how well it works of solid tumors (RECIST version 1.1), there should be at least one measurable lesion on imaging;
- The patient has not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc;
- ECOG score 0-1 points;
- Adequate organ function, people must meet the following laboratory indicators:
- In the past 14 days without using granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) was ≥ 1.5x109/L.
- Platelets ≥ 100 × 109/L without blood transfusion in the past 14 days.
- Hemoglobin\>9g/dL in the past 14 days without blood transfusion or use of erythropoietin;
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
- Aspartate transaminase (AST) and alanine transaminase (ALT) levels are ≤ 2.5 × ULN
- Blood creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated using Cockcroft Gault formula) ≥ 60 ml/min;
- Good coagulation function, 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 exceeds the normal range, people with total T3 (or FT3) and FT4 within the normal range can also be...
- The myocardial enzyme spectrum is within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included)
- For female people of childbearing age, a urine or serum pregnancy test with negative results should be conducted within 3 days prior to the first administration of the study drug (Day 1 of the first cycle). If the urine...
What rules you out
- Patients diagnosed with other malignant tumors that have not been cured within 5 years before the first administration (excluding skin basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ that has...
- Late stage rectal cancer patients with distant metastasis;
- Currently participating in treatment clinical research treatment, or having received other research drugs or used research instruments for treatment within 4 weeks before the first administration;
- 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 (such as CTLA-4, OX-40, CD137);
- Have received systemic treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effect within 2 weeks before the first administration;
- Within 2 years prior to the first administration, there has been an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants)...
- Within 7 days prior to the first administration of the study, the individual was receiving systemic corticosteroid therapy (excluding topical corticosteroids via nasal spray, inhalation, or other routes) or any other...
- Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Those who are known to be allergic to the active ingredients or excipients of the investigational drug Adabelimab and combination chemotherapy drugs;
- Prior to commencing treatment, the individual has not fully recovered from any toxicity and/or complications caused by any intervention measures (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss);
- Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
- 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 patients who meet the...
- Prior to the first administration, if the HBV viral load is less than 1000 copies/ml (200 IU/ml), people should receive anti HBV treatment throughout the entire study chemotherapy period to avoid viral reactivation
- For people with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of viral reactivation is necessary
- Active HCV infected people (HCV antibody positive and HCV-RNA level above the detection limit);
- Administer a live vaccine within 30 days prior to the first dose (Day 1 of the first cycle);Note: It is allowed to receive inactivated vaccine for seasonal influenza within 30 days before the first administration...
- Pregnant or lactating women;
- There are any serious or uncontrollable systemic diseases, such as:
- Resting electrocardiogram shows significant and difficult to control abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, grade II or higher heart block, ventricular arrhythmia...
- Unstable angina pectoris, congestive heart failure, chronic heart failure classified as NYHA ≥ 2;
- Myocardial infarction occurred within 6 months prior to enrollment;
- Poor blood pressure control (systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg);
- A history of non infectious pneumonia requiring corticosteroid treatment within the year prior to the first administration, or current clinical active interstitial lung disease;
- Active pulmonary tuberculosis;
- There are active or uncontrolled infections that require systemic treatment;
- There is clinical active diverticulitis, abdominal abscess, and gastrointestinal obstruction;
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- Poor control of diabetes (FBG\>10mmol/L);
- Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\>1.0 g;
- Patients with mental disorders who are unable to cooperate with treatment;
- Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the trial results, hinder the full participation of the people in the study, or other situations that the...
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 85 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.