Status:
NOT_YET_RECRUITING
MFOLFOXIRI Plus PD-1 Inhibitor Vs MFOLFOX6 As Neoadjuvant Therapy for Locally Advanced Colon Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Colon Cancer (stage II & III)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
In patients with high-risk stage II and stage III colon cancer, curative surgery followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become the standard treatment. However, 20 to 30% o...
Detailed Description
This trial is a two-arm, multicenter, open-label, prospective, randomized phase II study. Eligible patients with locally advanced (T4 or N2) colon cancer will be randomly assigned in a 1:1 ratio to re...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent.
- Histological or cytological documentation of adenocarcinoma of the colon (≥ 12 cm from the anal verge).
- Determined preoperatively by either spiral or multidetector CT: T4 or N2.
- Male or female subjects \> 18 years \< 70 of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- CT or MRI scans (done within 30 days of registration) of the chest, abdomen and pelvis all without clear evidence of distant metastatic (M1) disease.
- No clinically significant obstruction, perforation, or bleeding related to the primary tumor.
- No previous any systemic anticancer therapy for colon cancer disease.
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment
Exclusion
- Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
- Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
- Heart failure grade III/IV (NYHA-classification).
- Unresolved toxicity higher than CTCAE v.5.0 Grade 1 attributed to any prior therapy/procedure.
- Subjects with known allergy to the study drugs or to any of its excipients.
- Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
- Breast- feeding or pregnant women
- Lack of effective contraception.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06890624
Start Date
May 1 2025
End Date
May 1 2030
Last Update
March 27 2025
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