Neoadjuvant Short-Course Radiotherapy Followed by CAPOX Plus PD-1 Antibody and IL-2 in Locally Ad… (NCT06577194) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Short-Course Radiotherapy Followed by CAPOX Plus PD-1 Antibody and IL-2 in Locally Advanced Rectal Cancer (PRIDE01)
China35 participantsStarted 2024-10-09
Plain-language summary
A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy Followed by Sequential Immunotherapy with CAPOX Combined with PD-1 antibody and IL-2 for Locally Advanced Rectal Cancer
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 70 years at enrollment.
* Histologically confirmed rectal adenocarcinoma with the inferior tumor border within 12 cm of the anal verge.
* Pelvic MRI stage T3-T4, or any T stage with regional lymph-node involvement.
* Absolute neutrophil count \>=1.5 x 10\^9/L and platelet count \>=75 x 10\^9/L.
* Total bilirubin \<=1.5 x the upper limit of normal; aspartate aminotransferase and alanine aminotransferase \<=2.5 x the upper limit of normal.
* Serum creatinine \<=1.5 x the upper limit of normal.
* Eastern Cooperative Oncology Group performance status 0 or 1.
* Ability and willingness to provide written informed consent.
Exclusion Criteria:
* Distant metastatic disease.
* Recurrent rectal cancer.
* Tumor-related bleeding or perforation, or another condition requiring emergency surgery.
* Previous systemic anticancer treatment for rectal cancer.
* A concurrent malignancy other than colorectal cancer.
* Active autoimmune disease, or a history of autoimmune disease requiring systemic corticosteroids or other immunosuppressive therapy.
* Interstitial lung disease, non-infectious pneumonitis, or another uncontrolled systemic disease.
* Unresolved toxicity of grade 2 or higher from previous treatment, except anemia, alopecia or pigmentation changes.
* Previous treatment targeting PD-1, PD-L1 or CTLA-4.
* Pregnancy or breastfeeding.
* Human immunodeficiency virus infection or acquired immunodeficiency syndrome.
* Known hypersensitivity to any protocol t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete response rate (pCR or cCR)
Timeframe: Up to approximately 6 months after treatment initiation.
Trial details
NCT IDNCT06577194
SponsorThe First Affiliated Hospital with Nanjing Medical University