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New treatment option for Colorectal Cancer (CRC)
Official title Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT07448142
What this study is testing
What is Pucotenlimab?
Pucotenlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer (crc).
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 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.
- Phase 2: a mid-size study of how well it works
- 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
- 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).
You likely can't join if
- Clinical T4b disease, defined as tumor invasion into adjacent organs or structures on baseline imaging.
- Circumferential resection margin (CRM) \<2 mm or definite involvement of the mesorectal fascia on baseline MRI.
- 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...
See the full eligibility 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).
- Circumferential resection margin (CRM) ≥2 mm and no involvement of the mesorectal fascia on baseline MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate organ function as defined by:
- Absolute neutrophil count ≥1.5 × 10⁹/L
- Platelet count ≥100 × 10⁹/L
- Hemoglobin ≥90 g/L
- Total bilirubin ≤1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
- Creatinine clearance ≥50 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.
- Clinical T4b disease, defined as tumor invasion into adjacent organs or structures on baseline imaging.
- Circumferential resection margin (CRM) \<2 mm or definite involvement of the mesorectal fascia on baseline MRI.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guanggong, 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, Guanggong, 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.