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NOT YET RECRUITING
NCT07811076
PHASE1/PHASE2

Serine/Glycine-Restricted Diet With Chemoradiotherapy for Rectal Cancer

Sponsor: Xuelei Ma MD

View on ClinicalTrials.gov

Summary

This is a Phase Ib/II seamless, open-label, randomized controlled trial evaluating the safety and efficacy of a serine/glycine-restricted diet combined with neoadjuvant chemoradiotherapy and immunotherapy in patients with locally advanced rectal cancer (LARC). The study consists of two phases. Phase Ib is a non-randomized, single-arm safety run-in phase enrolling 6 patients, all of whom will receive the experimental regimen (serine/glycine-restricted diet plus CAPOX chemotherapy, PD-1 inhibitor, and short-course radiotherapy). The primary objective of Phase Ib is to assess safety, tolerability, and dietary compliance. If the safety criteria are met (≥3 grade diet-related adverse event rate ≤20% and compliance rate ≥70%), the study will proceed to Phase II. Phase II is a randomized, open-label, parallel-controlled phase in which 134 additional patients will be randomized in a 1:1 ratio to either the experimental group (serine/glycine-restricted diet plus standard neoadjuvant chemoradiotherapy and immunotherapy) or the control group (standard neoadjuvant chemoradiotherapy and immunotherapy alone). The total enrollment is 140 patients (6 in Phase Ib + 134 in Phase II). The primary endpoint is the complete response rate (pCR + cCR). Secondary endpoints include major pathological response (MPR) rate, R0 resection rate, mrTRG regression grade, event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse event profile, changes in serum amino acid levels, quality of life (EORTC QLQ-C30), and nutritional status. Exploratory endpoints include gut microbiome diversity and tumor immune microenvironment changes.

Official title: A Randomized Controlled Trial of Serine/Glycine-Restricted Diet Combined With Chemoradiotherapy and Immunotherapy for Neoadjuvant Treatment of Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-08-31

Completion Date

2029-06-30

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Serine/Glycine-Restricted Diet

A specialized liquid nutritional powder free of serine and glycine, supplemented with a list of permitted low-serine/glycine foods. Patients receive 30 kcal/kg/day energy and 1.5 g/kg/day protein for 4 weeks during the neoadjuvant treatment period.

DRUG

CAPOX Chemotherapy

Oxaliplatin 130 mg/m² IV on day 1 of each 3-week cycle, plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each cycle, for a total of 6 cycles.

DRUG

PD-1 Inhibitor

PD-1 inhibitor administered intravenously every 3 weeks in combination with CAPOX chemotherapy as part of the neoadjuvant regimen.

RADIATION

Short-Course Radiotherapy

25 Gy delivered in 5 fractions (5 Gy/fraction) over 1 week, administered during the second week of Cycle 1 (C2, Week 1), concurrent with capecitabine.

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China