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โ† Trials
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Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer

RecruitingPhase 2Ages 18 Years - 75 YearsAllSun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

This is a prospective, open-label, randomized, parallel-group phase II trial evaluating the efficacy and safety of a low-dose radiotherapy sensitization strategy combined with a PD-1 antibody (pucotenlimab) and CAPEOX as neoadjuvant therapy in patients with pMMR/MSS locally advanced rectal adenocarcinoma. Participants will be randomized 1:1 to receive either 2 Gy or 5 Gy low-dose radiotherapy. Low-dose radiotherapy is delivered as a single fraction of 2 Gy (Arm A) or 5 Gy (Arm B). On the day after radiotherapy, participants will start pucotenlimab 200 mg IV Q3W (administered on Day 2 of each 21-day cycle) plus CAPEOX chemotherapy. Tumor response will be assessed after two cycles using endoscopy and pelvic magnetic resonance imaging (MRI). Participants with non-progressive disease, defined as partial response (PR) or stable disease (SD), will receive no further low-dose radiotherapy and w

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria * Written informed consent provided prior to any study-specific procedures. * Age 18 to 75 years at the time of enrollment. * Histologically confirmed rectal adenocarcinoma. * Tumor located within 10 cm from the anal verge, as assessed by endoscopy or imaging. * Locally advanced disease, defined as clinical stage T2N+ or T3-T4a (any N) based on pelvic magnetic resonance imaging (MRI). * Proficient mismatch repair (pMMR) or microsatellite-stable (MSS) tumor status confirmed by immunohistochemistry or molecular testing. * No evidence of distant metastasis on preoperative imaging, including chest, abdominal, and pelvic computed tomography (CT). * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Adequate organ function as defined by: * Absolute neutrophil count โ‰ฅ1.5 ร— 10โน/L * Platelet count โ‰ฅ100 ร— 10โน/L * Hemoglobin โ‰ฅ90 g/L * Total bilirubin โ‰ค1.5 ร— upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) โ‰ค2.5 ร— ULN * Creatinine clearance โ‰ฅ50 mL/min * Thyroid-stimulating hormone (TSH) within normal limits * Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a protocol-defined period after the last dose. * Men with partners of childbearing potential must agree to use effective contraception during the study and for a protocol-defined period after the last dose. Exclusion Criteria * Clinical T4b disease, defined as tumor invasion into adjacent organs or structures on baseline imaging. * Evidence of distant metastasis outside the pelvis. * Prior pelvic or abdominal radiotherapy. * Prior treatment with immune checkpoint inhibitors or other systemic anticancer therapy for rectal cancer. * Active or history of autoimmune disease requiring systemic treatment, except for conditions considered low risk for recurrence (e.g., vitiligo, resolved childhood asthma). * Ongoing use of systemic immunosuppressive therapy, including corticosteroids equivalent to \>10 mg/day of prednisone, within 2 weeks prior to enrollment. * Known human immunodeficiency virus (HIV) infection. * Active hepatitis B virus infection with positive hepatitis B surface antigen and high viral load, or hepatitis C virus infection requiring treatment. * Uncontrolled active infection or other serious medical condition that, in the investigator's judgment, would compromise patient safety or study compliance. * History of another malignancy within 5 years, except for adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies with negligible risk of recurrence. * Known hypersensitivity or allergy to pucotenlimab, oxaliplatin, capecitabine, or any of their excipients. * Pregnant or breastfeeding women. * Any condition that, in the investigator's opinion, makes the participant unsuitable for study participation.
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What it tests

  • Low-dose radiotherapy
  • Pucotenlimab
  • CAPEOX/XELOX
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Where

1 site
Dept. of Colorectal Surgery, Sun Yat-sen University Cancer Center. Yuexiu District, Dongfeng East Road 651
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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