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NCT + PD1 + Ketogenic Diet and/or Vitamin C for LARC

ConditionsRectal AdenocarcinomaHigh-Risk CancerMSS
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

This trial does not accept healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

  • Short-Course Radiotherapy

    Radiation

    Patients undergo SCRT at a dose of 5Gy × 5 fractions

  • PD-1 monoclonal antibody

    Drug

    Patients receive six cycles of immunotherapy with serplulimab injection, a PD-1 monoclonal antibody, at a fixed dose of 200 mg per cycle.

  • mFOLFOX6 regimen

    Combination product

    Patients receive six cycles of the mFOLFOX6 regimen, consisting of oxaliplatin (85 mg/m²) and leucovorin (200 mg/m²) administered intravenously over 2 hours, followed by a bolus of fluorouracil (400 mg/m²) and a continuous infusion of fluorouracil (2,400 mg/m²) over 46 hours.

  • Ketogenic Diet

    Behavioral

    A modified Atkins diet (MAD) is used, with the goal of maintaining nutritional ketosis, defined as a blood β-hydroxybutyrate (BHB) level of 1.5-3.0 mmol/L. The ketogenic dietary intervention begins after completion of SCRT and continues throughout six cycles of mFOLFOX6 chemotherapy and immunotherapy until the completion of neoadjuvant treatment.

  • Surgical resection

    Procedure/Surgery

    Surgery either local excition or total mesorectal excision is performed 2 weeks after the completion of neoadjuvant therapy.

  • Vitamin C

    Drug

    Vitamin C is administered intravenously at a dose of 1.5 g/kg/day, diluted in 250-500 mL of normal saline, over 2 hours for 3 consecutive days (Days 1-3). Each treatment cycle is repeated every 2 weeks and synchronized with the neoadjuvant treatment cycle.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Short-Course Radiotherapy + mFOLFOX6 + PD-1Sham comparator 4 interventions
Group B: Short-Course Radiotherapy + mFOLFOX6 + PD-1 + Ketogenic DietExperimental treatment 5 interventions
Group C: Short-Course Radiotherapy + mFOLFOX6 + PD-1 + Vitamin CExperimental treatment 5 interventions
Group D: Short-Course Radiotherapy + mFOLFOX6 + PD-1 + Ketogenic Diet + Vitamin CExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

pCR rate

Pathological complete response rate, ypT0N0 for TME surgery and ypT0rN0 for local excision

Time frame
1 year

Secondary outcomes

1

Adverse Events Associated with Neoadjuvant Therapy

Incidence of adverse events related to neoadjuvant therapy as assessed by CTCAE v5.0

Time frame
1 year
2

MPR

Major pathological response rate

Time frame
1 year
3

Neoadjuvant therapy completion rate Neoadjuvant therapy completion rate Neoadjuvant therapy completion rate Neoadjuvant therapy completion rate

Completion rate of neoadjuvant therapy

Time frame
1 year
4

R0 resection rate

R0 resection rate in participants

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sixth Affiliated Hospital, Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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