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NCT07912463

PHASE1/PHASE2

Phase Ib/II Trial of 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, clinical trial evaluating the safety and efficacy of a serine/glycine-restricted diet combined with neoadjuvant chemoradiotherapy 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 (a serine/glycine-restricted diet plus CAPOX chemotherapy and long-course radiotherapy). The primary objective of Phase Ib is to assess the safety, tolerability, and dietary compliance. If the safety criteria are met in Phase Ib (≥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 120 additional patients will be randomized in a 1:1 ratio to either the experimental group (serine/glycine-restricted diet plus standard neoadjuvant chemoradiotherapy) or the control group (standard neoadjuvant chemoradiotherapy alone). The total enrollment is 126 patients (6 in Phase Ib + 120 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: Phase Ib/II Clinical Trial of Serine/Glycine-Restricted Diet Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2026-11-15

Completion Date

2029-11-15

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Locally Advanced Rectal Cancer

Interventions

DIETARY_SUPPLEMENT

Serine/Glycine-Restricted Diet

A specialized liquid nutritional powder free of serine and glycine, supplemented with a specified list of low-serine/glycine foods. Patients receive 30 kcal/kg/day energy and 1.5 g/kg/day protein for 7-8 weeks during the neoadjuvant treatment period.

DRUG

CAPOX Chemotherapy

Oxaliplatin and capecitabine combination chemotherapy administered for 6 cycles as part of the standard neoadjuvant regimen.

RADIATION

Long-Course Radiotherapy

Pelvic radiotherapy delivered with a total dose of 45.0-50.4 Gy in 25-28 fractions, concurrent with capecitabine.

Inclusion Criteria: * Written informed consent obtained prior to any study-related procedures. * Male or female, aged 18-80 years. * Histologically confirmed locally advanced mid-to-upper rectal cancer, staged as cT3, cT4, or node-positive by pelvic MRI. * ECOG performance status score of 0 or 1. * NRS-2002 score \< 3. * BMI ≥ 18.5 kg/m². * Capable of oral intake or via feeding tube, and able to tolerate enteral nutrition. * Adequate organ function meeting the following laboratory criteria: ANC ≥ 1.5×10⁹/L (without G-CSF within 14 days); Platelet count ≥ 100×10⁹/L; Hemoglobin ≥ 9 g/dL (without transfusion or erythropoietin within 7 days); Serum albumin ≥ 3.0 g/dL; Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5× ULN; Creatinine clearance ≥ 50 mL/min or serum creatinine ≤ 1.5× ULN; INR ≤ 1.5× ULN, PT and APTT ≤ 1.5× ULN; Urine protein \< 2+; Cardiac enzymes within normal range. * Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to study treatment and agree to use highly effective contraception for at least 6 months after the last dose. * All patients at risk of pregnancy must use highly effective contraceptive methods during the treatment period and up to 120 days (or 180 days after last chemotherapy dose) after the last dose of study treatment. Exclusion Criteria: * Stage I or Stage IV rectal cancer. * Cognitive impairment or psychiatric disorders preventing comprehension of the study content. * Central nervous system or meningeal metastases. * Clinically symptomatic moderate to severe ascites requiring therapeutic paracentesis. * Uncontrolled or moderate to severe pleural effusion and pericardial effusion. * Severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction; tracheoesophageal fistula, gastrointestinal perforation or fistula, intra-abdominal abscess; gastrointestinal bleeding (CTCAE grade ≥ 3 within 6 months or grade ≥ 2 within 3 months before study treatment). * Any other condition that may affect the study results or lead to forced discontinuation as judged by the investigator (e.g., alcohol or drug abuse, serious concurrent diseases, severe laboratory abnormalities). * Known allergy to the study drugs or nutritional powder active ingredients or excipients. * Poorly controlled diabetes mellitus. * Severe cardiovascular/cerebrovascular diseases, including CVA, TIA, myocardial infarction, major vascular disease within 6 months; uncontrolled symptomatic cardiac disease (e.g., unstable angina, NYHA class II or higher heart failure, LVEF \< 50% on echocardiography, or severe uncontrolled arrhythmia). * Pregnant or lactating women. * Any other condition that the investigator considers unsuitable for enrollment.