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Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer: A Randomized Controlled Trial

NCT07755124 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-08-10

No results posted yet for this study

Summary

This study evaluates whether an arginine-free diet combined with chemoradiotherapy can improve treatment outcomes in patients with locally advanced rectal cancer. Our previous study showed that an arginine-free diet is safe and may boost the body's immune response against tumors.

The study has two phases. The first phase (6 patients) tests the safety of the diet. The second phase (134 patients) randomly assigns participants to receive either the arginine-free diet plus standard chemoradiotherapy or standard chemoradiotherapy alone.

The arginine-free diet is provided as a liquid nutritional formula for 4 weeks. The main goal is to see if the diet increases the complete response rate (tumor disappearance). We will also evaluate survival outcomes, side effects, and quality of life.

Conditions

  • Rectal Neoplasms

Interventions

DIETARY_SUPPLEMENT

Arginine-Deprived Diet

A nutritionally complete liquid formula providing 1978 kJ energy, 16.6 g protein, 22.2 g fat, 49.4 g carbohydrate, and 4.32 g dietary fiber per 100 g, with all essential amino acids except arginine. Participants receive the formula as a total diet replacement for 4 weeks during chemoradiotherapy. Daily intake is calculated based on standard body weight at 30 kcal/kg/day energy and 1.5 g/kg/day protein, typically 3.5-8.5 bottles per day (70 g/bottle, reconstituted in 300 mL warm water).

RADIATION

Short-Course Radiotherapy (SCRT)

Short-course radiotherapy delivered at 25 Gy in 5 fractions over 5 consecutive days during the first week of Cycle 2 (C2D1-C2D5, day 21-28 of the treatment schedule).

DRUG

CAPOX + PD-1 Inhibitor

CAPOX regimen (oxaliplatin 130 mg/m² IV on day 1 + capecitabine 1000 mg/m² oral twice daily on days 1-14) combined with PD-1 inhibitor (200 mg IV on day 1) every 3 weeks for 6 cycles.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-14
Primary Completion
2028-08-31
Completion
2029-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755124 on ClinicalTrials.gov