OncoMatch/Clinical Trials/NCT07888309
SCRT + Fruquintinib + Tislelizumab + CAPOX Versus SCRT + Tislelizumab + CAPOX as Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer
Official title: Short-Course Radiotherapy Followed by Fruquintinib Plus Tislelizumab and CAPOX Versus Short-Course Radiotherapy Followed by Tislelizumab and CAPOX for Neoadjuvant Treatment of Locally Advanced Low Rectal Cancer: A Randomized Controlled Trial
Is NCT07888309 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Fruquintinib and Tislelizumab for rectal neoplasms.
Treatment: Fruquintinib · Tislelizumab · CAPOX — The goal of this randomized controlled clinical trial is to learn if adding fruquintinib to short-course radiotherapy, tislelizumab, and CAPOX can improve neoadjuvant treatment response and is safe for adults with locally advanced low rectal cancer. The main questions it aims to answer are: * Does adding fruquintinib increase the pathological complete response (pCR) rate after neoadjuvant therapy? * What adverse events do participants experience when fruquintinib is added to the regimen? Researchers will compare short-course radiotherapy followed by fruquintinib + tislelizumab + CAPOX with short-course radiotherapy followed by tislelizumab + CAPOX to see if adding fruquintinib improves the tumor response to neoadjuvant treatment. Participants will: * Receive short-course radiotherapy (e.g., 25 Gy in 5 daily fractions over 1 week) * Receive either fruquintinib + tislelizumab + CAPOX (experimental arm) or tislelizumab + CAPOX (control arm) for the neoadjuvant cycles * Attend scheduled visits for tumor assessment (MRI, endoscopy, CT), blood tests, and adverse-event monitoring * Undergo total mesorectal excision (TME) surgery after neoadjuvant treatment and have the specimen evaluated for pathological response
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Colorectal Cancer
Disease stage
Required: Stage III (other)
locally advanced rectal adenocarcinoma; cT4a or cT4b; cN2; EMVI; MRF involvement; enlarged lateral lymph nodes
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; platelets ≥ 75 × 10⁹/L; hemoglobin ≥ 90 g/L; WBC ≥ 3.0 × 10⁹/L
Kidney function
serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min
Liver function
total bilirubin ≤ 1.5 × ULN (Gilbert's ≤ 3 × ULN; with liver metastases ≤ 3 × ULN); ALT ≤ 2.5 × ULN and AST ≤ 2.5 × ULN (with liver metastases ≤ 5 × ULN)
Cardiac function
LVEF ≥ 50%
Adequate function of major organs, including: Hematology (ANC ≥ 1.5 × 10⁹/L; platelets ≥ 75 × 10⁹/L; hemoglobin ≥ 90 g/L; WBC ≥ 3.0 × 10⁹/L); Blood chemistry: total bilirubin ≤ 1.5 × ULN (Gilbert's ≤ 3 × ULN; with liver metastases ≤ 3 × ULN); ALT ≤ 2.5 × ULN and AST ≤ 2.5 × ULN (with liver metastases ≤ 5 × ULN); serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min; Coagulation: INR ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN; PT ≤ 1.5 × ULN; Doppler ultrasound: LVEF ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07888309 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage III is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages