Different-Dose SCRT Plus CAPOX, PD-1 Blockade and IL-2 in LARC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital with Nanjing Medical University
About this trial
This prospective, randomized phase II trial is designed to evaluate whether low-dose short-course radiotherapy differs from common-dose short-course radiotherapy in terms of efficacy when both regimens are sequentially combined with CAPOX, a PD-1 monoclonal antibody, and interleukin-2 (IL-2) in patients with locally advanced rectal cancer. The study is based on findings from our previous single-center, single-arm PRIDE01 study, in which neoadjuvant short-course radiotherapy followed by systemic chemoimmunotherapy and IL-2 demonstrated encouraging antitumor activity relative to historical short-course radiotherapy-based approaches. The current trial aims to provide more robust clinical evidence regarding the potential role of low-dose radiotherapy combined with IL-2 as a sensitization strategy in multimodal neoadjuvant therapy. By comparing complete response rates between the two radiotherapy dose levels, this study may help define an optimized neoadjuvant approach and support future organ-preservation strategies for patients with locally advanced rectal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients aged 18 to 70 years.
Histologically confirmed rectal adenocarcinoma with the distal margin of the tumor located within 12 cm of the anal verge.
MRI-based clinical stage T3-T4 or any T with lymph node-positive (N+) disease.
Adequate hematologic, hepatic, and renal function defined as: absolute neutrophil count >=1.5 x 10^9/L; platelet count >=75 x 10^9/L; serum total bilirubin <=1.5 x upper normal limit (UNL); aspartate aminotransferase <=2.5 x UNL; alanine aminotransferase <=2.5 x UNL; serum creatinine <=1.5 x UNL.
Disqualifiers
Metastatic disease (Stage IV).
Recurrent rectal cancer.
Concurrent active bleeding, perforation, or other complicated conditions requiring emergency surgery.
Prior systemic anticancer therapy for rectal cancer.
Trial design
Design model
Parallel
Treatments tested in this trial
Sintilimab + IL-2 Combined with CAPOX
DrugEnhanced immuno-chemotherapy cocktail.
Short-course low-dose radiotherapy
RadiationA short-course radiotherapy (SCRT, 10Gy/5f)
Short-course standard-dose radiotherapy
RadiationA short-course radiotherapy (SCRT, 25Gy/5f)
Treatment groups
122 Participants
are divided into 2 treatment groupsGroup A: Short-course standard-dose radiotherapy, IL-2 and Sintilimab Combined with CAPOXActive comparator 2 interventions
Group B: Short-course low-dose radiotherapy, IL-2 and Sintilimab Combined with CAPOXExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Complete remission
Complete remission rate defined as the sum of pathological complete remission (pCR) and clinical complete remission (cCR)
Time frame
Two yearsSecondary outcomes
1
Event-free survival (EFS)
Event-free survival (EFS), defined as the time from initiation of radiotherapy to the first occurrence of disease progression, locoregional recurrence, distant metastasis, or death from any cause.
Time frame
Three years2
Disease-free survival rate
Disease-free survival (DFS), defined as the time from the date of surgery to the first documented locoregional recurrence, distant metastasis, or death from any cause.
Time frame
Three years3
Overall survival rate
Overall survival (OS), defined as the time from treatment initiation to death from any cause
Time frame
Three years4
Locoregional recurrence rate
Locoregional recurrence rate assessed by clinical, radiologic, and/or pathologic evaluation
Time frame
Three yearsSponsors and contacts
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Source ClinicalTrials.gov