Rectal Cancer PatientsPhase 1/2-Arg CRTNCT07912346
Arginine-Restricted Diet Combined With Chemoradiotherapy in Neoadjuvant Rectal Cancer: A Phase Ib/II Trial
A Phase 1/2 study testing Arginine-Restricted Diet, CAPOX Chemotherapy and Long-Course Radiotherapy in people with Rectal Cancer Patients, run by Xuelei Ma MD.
Trial summary
This is a Phase Ib/II clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of an arginine-restricted diet combined with standard neoadjuvant chemoradiotherapy in patients with locally advanced middle/high rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer Patients
- What is being tested?
- Arginine-Restricted Diet, CAPOX Chemotherapy and Long-Course Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Oct 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent prior to any study-related procedures.
- Male or female, aged 18 to 80 years.
- Histologically or radiologically confirmed locally advanced middle/high rectal cancer (cT3, cT4, or lymph node positive) assessed by pelvic MRI. The distance from the lower edge of the tumor to the anal verge must be >5 cm and ≤15 cm.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Nutritional Risk Screening (NRS-2002) score < 3.
- Body mass index (BMI) ≥ 18.5 kg/m² (may be relaxed to ≥ 17.0 kg/m² due to tumor hypermetabolism).
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- Ability to take oral food or enteral nutrition via a feeding tube, and able to tolerate enteral nutrition.
- Adequate organ function, defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- Platelet count ≥ 100 × 10^9/L;
- Hemoglobin ≥ 9 g/dL;
- 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+ (if ≥ 2+, 24-hour urine protein must be < 2.0 g);
- Normal myocardial enzyme profile.
- Women of childbearing potential must have a negative serum HCG test within 3 days prior to treatment, must not be lactating, and must agree to use effective contraception.
- All subjects (male and female) with reproductive potential must agree to use highly effective contraception during the study and for at least 120 days (or 180 days after the last chemotherapy dose) after the last dose of study treatment.
Who cannot join
- Stage I or Stage IV rectal cancer.
- Cognitive impairment or psychiatric illness preventing the patient from understanding the study content.
- Central nervous system or meningeal metastases.
- Clinically symptomatic moderate or severe ascites (requiring therapeutic paracentesis within 2 weeks before study treatment).
- Uncontrolled, moderate, or severe pleural effusion and pericardial effusion.
- Severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical ileus; tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess; gastrointestinal bleeding (CTCAE Grade 3 or higher within 6 months, or Grade 2 or higher within 3 months prior to study treatment).
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- Other factors that may affect study results or lead to forced termination (e.g., alcoholism, drug abuse, severe concurrent diseases requiring combined treatment, significantly abnormal laboratory values, or social/family factors).
- Known allergy to the active ingredients or excipients of the study drugs or nutritional powder.
- Poorly controlled diabetes mellitus.
- Severe cardiovascular and cerebrovascular diseases (e.g., cerebrovascular accident, transient ischemic attack, myocardial infarction within 6 months; unstable angina; NYHA Class II or higher heart failure; left ventricular ejection fraction < 50%; or severe arrhythmia uncontrolled by medication).
- Pregnant or lactating women.
- Any other conditions deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib/II Clinical Trial of Arginine-Restricted Diet Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer
This is a Phase Ib/II clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of an arginine-restricted diet combined with standard neoadjuvant chemoradiotherapy in patients with locally advanced middle/high rectal cancer.
Background: Standard neoadjuvant chemoradiotherapy is the standard treatment for locally advanced rectal cancer to shrink tumors before surgery. However, the rate of complete tumor disappearance (pathological complete response) with standard treatment remains relatively low (around 10-20%). Arginine is an amino acid that supports tumor growth and immune escape. Preclinical studies and our previous Phase I trial (NCT07038044) suggest that restricting arginine in the diet can alter tumor metabolism and enhance the body's anti-tumor immune response.
Read more
Study Design: The study consists of two phases. Phase Ib is a single-arm safety run-in, where 6 patients will receive the arginine-restricted diet plus standard chemoradiotherapy.
Phase II is a randomized, open-label, controlled phase. Approximately 120 patients will be randomly assigned in a 1:1 ratio to either the experimental group or the control group. Neither the patient nor the doctor can choose the group.
Interventions:
Standard Treatment: All participants will receive standard CAPOX chemotherapy (oxaliplatin and capecitabine) and long-course radiotherapy.
Arginine-Restricted Diet: Patients in the experimental group will consume a specially formulated, nutritionally complete, arginine-restricted nutritional powder combined with specific low-arginine foods for 7-8 weeks during the radiotherapy period, replacing their normal diet. Patients in the control group will maintain a normal diet.
Objectives: The primary objective is to evaluate whether this dietary intervention can improve the complete response rate (including pathological complete response [pCR] and clinical complete response [cCR]) compared to standard treatment alone. Secondary objectives include assessing safety (adverse events), surgical outcomes (R0 resection rate), survival outcomes (event-free survival, progression-free survival, overall survival), and changes in nutritional and immune status.
- Conditions
- Rectal Cancer Patients
- Being tested
- Arginine-Restricted Diet, CAPOX Chemotherapy, Long-Course Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginine-Restricted DietDietary supplement
Participants receive a specially formulated arginine-free nutritional powder combined with specific low-arginine foods. This diet replaces the patient's normal food intake for 7-8 weeks during the radiotherapy period. Energy and protein targets are maintained at 30 kcal/kg/day and 1.5 g/kg/day, respectively.
CAPOX ChemotherapyDrug
Standard neoadjuvant chemotherapy using the CAPOX regimen (Oxaliplatin plus Capecitabine) for a total of 6 cycles, administered every 3 weeks. Capecitabine is also taken orally concurrently during the radiotherapy period.
Long-Course RadiotherapyRadiation
Patients receive long-course neoadjuvant radiotherapy administered between Cycle 1 and Cycle 2 of CAPOX chemotherapy. The total dose is 45.0-50.4 Gy delivered in 25-28 fractions, concurrent with oral capecitabine.
| Study group | Role | What they receive |
|---|---|---|
| Arginine-Restricted Diet + Chemoradiotherapy | Experimental | Patients (including Phase Ib and Phase II) receive standard neoadjuvant chemoradiotherapy (CAPOX regimen + long-course radiotherapy) combined with a 7-8 week arginine-restricted diet. The diet replaces normal food with a specially formulated arginine-free nutritional powder and specific low-arginine foods. Receives: Dietary Supplement: Arginine-Restricted Diet; Drug: CAPOX Chemotherapy; Radiation: Long-Course Radiotherapy |
| Standard Chemoradiotherapy + Normal Diet | Other | Patients (Phase II only) receive standard neoadjuvant chemoradiotherapy (CAPOX regimen + long-course radiotherapy) while maintaining a normal diet without arginine restriction. Receives: Drug: CAPOX Chemotherapy; Radiation: Long-Course Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Complete Response (pCR and cCR)
Measured: At the time of radical surgery (for pCR) or after the completion of all neoadjuvant therapy and before surgery (for cCR), approximately 24 to 26 weeks after the initiation of neoadjuvant treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuelei Ma MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuelei Ma MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912346
- Sponsor's protocol ID
- Approval No. 1645 (2026)
- Acronym
- -Arg CRT
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial of Arginine-Restricted Diet Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer
- ClinicalTrials.gov ID
- NCT07912346
- Acronym / sponsor ID
- -Arg CRT / Approval No. 1645 (2026)
- Conditions
- Rectal Cancer Patients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Xuelei Ma MDUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ib/II clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of an arginine-restricted diet combined with standard neoadjuvant chemoradiotherapy in patients with locally advanced middle/high rectal cancer.
Background: Standard neoadjuvant chemoradiotherapy is the standard treatment for locally advanced rectal cancer to shrink tumors before surgery. However, the rate of complete tumor disappearance (pathological complete response) with standard treatment remains relatively low (around 10-20%). Arginine is an amino acid that supports tumor growth and immune escape. Preclinical studies and our previous Phase I trial (NCT07038044) suggest that restricting arginine in the diet can alter tumor metabolism and enhance the body's anti-tumor immune response.
Study Design: The study consists of two phases. Phase Ib is a single-arm safety run-in, where 6 patients will receive the arginine-restricted diet plus standard chemoradiotherapy.
Phase II is a randomized, open-label, controlled phase. Approximately 120 patients will be randomly assigned in a 1:1 ratio to either the experimental group or the control group. Neither the patient nor the doctor can choose the group.
Interventions:
Standard Treatment: All participants will receive standard CAPOX chemotherapy (oxaliplatin and capecitabine) and long-course radiotherapy.
Arginine-Restricted Diet: Patients in the experimental group will consume a specially formulated, nutritionally complete, arginine-restricted nutritional powder combined with specific low-arginine foods for 7-8 weeks during the radiotherapy period, replacing their normal diet. Patients in the control group will maintain a normal diet.
Objectives: The primary objective is to evaluate whether this dietary intervention can improve the complete response rate (including pathological complete response [pCR] and clinical complete response [cCR]) compared to standard treatment alone. Secondary objectives include assessing safety (adverse events), surgical outcomes (R0 resection rate), survival outcomes (event-free survival, progression-free survival, overall survival), and changes in nutritional and immune status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arginine-Restricted Diet + Chemoradiotherapy | Experimental | Dietary Supplement: Arginine-Restricted Diet, Drug: CAPOX Chemotherapy, Radiation: Long-Course RadiotherapyPatients (including Phase Ib and Phase II) receive standard neoadjuvant chemoradiotherapy (CAPOX regimen + long-course radiotherapy) combined with a 7-8 week arginine-restricted diet. The diet replaces normal food with a specially formulated arginine-free nutritional powder and specific low-arginine foods. |
| Standard Chemoradiotherapy + Normal Diet | Other | Drug: CAPOX Chemotherapy, Radiation: Long-Course RadiotherapyPatients (Phase II only) receive standard neoadjuvant chemoradiotherapy (CAPOX regimen + long-course radiotherapy) while maintaining a normal diet without arginine restriction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Signed written informed consent prior to any study-related procedures.
- Male or female, aged 18 to 80 years.
- Histologically or radiologically confirmed locally advanced middle/high rectal cancer (cT3, cT4, or lymph node positive) assessed by pelvic MRI. The distance from the lower edge of the tumor to the anal verge must be >5 cm and ≤15 cm.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Nutritional Risk Screening (NRS-2002) score < 3.
Key exclusion criteria (12 listed)
- Stage I or Stage IV rectal cancer.
- Cognitive impairment or psychiatric illness preventing the patient from understanding the study content.
- Central nervous system or meningeal metastases.
- Clinically symptomatic moderate or severe ascites (requiring therapeutic paracentesis within 2 weeks before study treatment).
- Uncontrolled, moderate, or severe pleural effusion and pericardial effusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arginine-Restricted DietParticipants receive a specially formulated arginine-free nutritional powder combined with specific low-arginine foods. This diet replaces the patient's normal food intake for 7-8 weeks during the radiotherapy period. Energy and protein targets are maintained at 30 kcal/kg/day and 1.5 g/kg/day, respectively. | Dietary supplement | Arginine-Restricted Diet + Chemoradiotherapy |
| CAPOX ChemotherapyStandard neoadjuvant chemotherapy using the CAPOX regimen (Oxaliplatin plus Capecitabine) for a total of 6 cycles, administered every 3 weeks. Capecitabine is also taken orally concurrently during the radiotherapy period. | Drug | Arginine-Restricted Diet + Chemoradiotherapy, Standard Chemoradiotherapy + Normal Diet |
| Long-Course RadiotherapyPatients receive long-course neoadjuvant radiotherapy administered between Cycle 1 and Cycle 2 of CAPOX chemotherapy. The total dose is 45.0-50.4 Gy delivered in 25-28 fractions, concurrent with oral capecitabine. | Radiation | Arginine-Restricted Diet + Chemoradiotherapy, Standard Chemoradiotherapy + Normal Diet |
Primary outcome
Rate of Complete Response (pCR and cCR)
Time frame: At the time of radical surgery (for pCR) or after the completion of all neoadjuvant therapy and before surgery (for cCR), approximately 24 to 26 weeks after the initiation of neoadjuvant treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Arginine-Restricted Diet, CAPOX Chemotherapy and Long-Course Radiotherapy in people with Rectal Cancer Patients, run by Xuelei Ma MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuelei Ma, MD (+8613408410416, drmaxuelei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complete Response (pCR and cCR) (time frame: At the time of radical surgery (for pCR) or after the completion of all neoadjuvant therapy and before surgery (for cCR), approximately 24 to 26 weeks after the initiation of neoadjuvant treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.