NCT + PD1 + Ketogenic Diet and/or Vitamin C for LARC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
To explore the efficacy and safety of adding a ketogenic diet and/or high-dose intravenous vitamin C to neoadjuvant short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with serplulimab in patients with locally advanced pMMR/MSS rectal adenocarcinoma through a prospective, randomized, controlled phase II clinical study, providing preliminary evidence for optimizing neoadjuvant treatment strategies for this population.
Eligibility criteria
Qualifiers
White blood cell count (WBC) ≥3.0 × 10⁹/L or absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
Hemoglobin (HGB) ≥80 g/L;
Platelet count (PLT) ≥100 × 10⁹/L;
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3.0 × the upper limit of normal (ULN);
Disqualifiers
Arrhythmia requiring antiarrhythmic therapy, except for beta-blockers or digoxin; symptomatic coronary artery disease; myocardial ischemia, including myocardial infarction within the previous 6 months; or congestive heart failure greater than New York Heart Association (NYHA) class II.
Severe hypertension that is inadequately controlled with medication.
A history of human immunodeficiency virus (HIV) infection or active chronic hepatitis B or C infection with a high viral DNA copy number.
Active tuberculosis (TB), current anti-tuberculosis treatment, or receipt of anti-tuberculosis treatment within 1 year before screening.
Trial design
Treatments tested in this trial
- Short-Course Radiotherapy
- PD-1 monoclonal antibody
- mFOLFOX6 regimen
- Ketogenic Diet
- Surgical resection
- Vitamin C
Treatment groups
100 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov