Rectal NeoplasmsPhase 1/2NCT07755124
Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer: A Randomized Controlled Trial
A Phase 1/2 study testing Arginine-Deprived Diet, Short-Course Radiotherapy (SCRT) and CAPOX + PD-1 Inhibitor in people with Rectal Neoplasms, run by West China Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Arginine-Deprived Diet, Short-Course Radiotherapy (SCRT) and CAPOX + PD-1 Inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 14 Aug 2026to 30 Jun 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.
- Locally advanced mid-low rectal cancer staged as cT3, cT4, or node-positive by rectal MRI.
- ECOG performance status 0-1.
- NRS-2002 score < 3.
- BMI ≥ 18.5 kg/m² (may be adjusted based on actual conditions).
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- Able to take food orally or via feeding tube and tolerate enteral nutrition.
- Adequate organ function as defined by the following laboratory criteria:
- ANC ≥ 1.5 × 10⁹/L (no G-CSF within 14 days);
- Platelet count ≥ 100 × 10⁹/L;
- Hemoglobin ≥ 9 g/dL (no transfusion or erythropoietin within 7 days);
- Serum albumin ≥ 3.0 g/dL;
- Total bilirubin ≤ 1.5 × ULN;
- AST/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 < 2.0 g allowed);
- Cardiac enzyme profile within normal limits.
- Women of childbearing potential must agree to use reliable contraception from signing informed consent to at least 6 months after the last dose, with a negative serum HCG test within 3 days before treatment and non-lactating status.
- All participants at risk of pregnancy must use contraceptive methods with a failure rate of < 1% per year throughout treatment until 120 days after the last study drug dose (or 180 days after the last chemotherapy).
Who cannot join
- Stage I or IV rectal cancer.
- Cognitive impairment or psychiatric disorders that interfere with understanding the study content.
- Central nervous system or meningeal metastases.
- Clinically symptomatic moderate or severe ascites (requiring therapeutic paracentesis within 2 weeks before starting study treatment; patients with minimal asymptomatic ascites on imaging may be enrolled).
- 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, or intra-abdominal abscess; gastrointestinal bleeding with CTCAE grade ≥ 3 within 6 months or CTCAE grade ≥ 2 within 3 months before study treatment.
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- Other factors that may affect study results or cause forced termination (as judged by the investigator), such as alcoholism, drug abuse, other serious diseases requiring combined treatment (including psychiatric disorders), severe laboratory abnormalities, family or social factors, and other conditions that may affect patient safety or study data collection.
- Known allergy to active ingredients or excipients of the study drug or nutritional powder.
- Poorly controlled diabetes mellitus.
- Severe cardiovascular and cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and major vascular diseases within 6 months before enrollment; poorly controlled symptomatic cardiac diseases, such as unstable angina, NYHA class ≥ II heart failure, LVEF < 50% on echocardiography, or severe arrhythmia uncontrolled by medication.
- Pregnancy or lactation.
- 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 Randomized Controlled Trial of Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer
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
- Being tested
- Arginine-Deprived Diet, Short-Course Radiotherapy (SCRT), CAPOX + PD-1 Inhibitor
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginine-Deprived DietDietary supplement
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).
Short-Course Radiotherapy (SCRT)Radiation
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).
CAPOX + PD-1 InhibitorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arginine-Deprived Diet + Chemoimmunotherapy + SCRT | Experimental | Not described Receives: Dietary Supplement: Arginine-Deprived Diet; Radiation: Short-Course Radiotherapy (SCRT); Drug: CAPOX + PD-1 Inhibitor |
| Standard Chemoimmunotherapy with SCRT | Active comparator | Participants in the control arm receive standard chemoradiotherapy with normal diet. The treatment regimen includes CAPOX chemotherapy (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, plus short-course radiotherapy (25 Gy in 5 fractions) in the first week of cycle 2. Diet is unrestricted. No arginine-deprived diet is administered. Receives: Radiation: Short-Course Radiotherapy (SCRT); Drug: CAPOX + PD-1 Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate (pCR + cCR)
Complete response rate is defined as the proportion of participants achieving either pathological complete response (pCR) or clinical complete response (cCR). pCR is defined as no residual tumor cells in the resected tumor tissue and regional lymph nodes. cCR is defined as no evidence of residual tumor in the primary lesion and regional lymph nodes (ycT0N0) after neoadjuvant treatment, assessed by rectal examination, endoscopy, pelvic MRI (T2WI/DWI), and serum CEA level.
Measured: From enrollment to postoperative pathological assessment, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start14 Aug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuelei Ma MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755124
- Sponsor's protocol ID
- Approval No. 1281 (2026)
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Dietary Arginine Deprivation Combined With Chemoradiotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07755124
- Acronym / sponsor ID
- Approval No. 1281 (2026)
- Conditions
- Rectal Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 14 Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 10 Aug 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arginine-Deprived Diet + Chemoimmunotherapy + SCRT | Experimental | Dietary Supplement: Arginine-Deprived Diet, Radiation: Short-Course Radiotherapy (SCRT), Drug: CAPOX + PD-1 Inhibitor |
| Standard Chemoimmunotherapy with SCRT | Active comparator | Radiation: Short-Course Radiotherapy (SCRT), Drug: CAPOX + PD-1 InhibitorParticipants in the control arm receive standard chemoradiotherapy with normal diet. The treatment regimen includes CAPOX chemotherapy (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, plus short-course radiotherapy (25 Gy in 5 fractions) in the first week of cycle 2. Diet is unrestricted. No arginine-deprived diet is administered. |
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.
- Locally advanced mid-low rectal cancer staged as cT3, cT4, or node-positive by rectal MRI.
- ECOG performance status 0-1.
- NRS-2002 score < 3.
Key exclusion criteria (12 listed)
- Stage I or IV rectal cancer.
- Cognitive impairment or psychiatric disorders that interfere with understanding the study content.
- Central nervous system or meningeal metastases.
- Clinically symptomatic moderate or severe ascites (requiring therapeutic paracentesis within 2 weeks before starting study treatment; patients with minimal asymptomatic ascites on imaging may be enrolled).
- Uncontrolled or moderate to 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-Deprived DietA 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). | Dietary supplement | Arginine-Deprived Diet + Chemoimmunotherapy + SCRT |
| 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). | Radiation | Arginine-Deprived Diet + Chemoimmunotherapy + SCRT, Standard Chemoimmunotherapy with SCRT |
| CAPOX + PD-1 InhibitorCAPOX 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. | Drug | Arginine-Deprived Diet + Chemoimmunotherapy + SCRT, Standard Chemoimmunotherapy with SCRT |
Primary outcome
Complete Response (CR) Rate (pCR + cCR)
Time frame: From enrollment to postoperative pathological assessment, approximately 6 months
Complete response rate is defined as the proportion of participants achieving either pathological complete response (pCR) or clinical complete response (cCR). pCR is defined as no residual tumor cells in the resected tumor tissue and regional lymph nodes. cCR is defined as no evidence of residual tumor in the primary lesion and regional lymph nodes (ycT0N0) after neoadjuvant treatment, assessed by rectal examination, endoscopy, pelvic MRI (T2WI/DWI), and serum CEA level.
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 10 Aug 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-Deprived Diet, Short-Course Radiotherapy (SCRT) and CAPOX + PD-1 Inhibitor in people with Rectal Neoplasms, run by West China Hospital.
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 10 Aug 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 (+86 13408410416, drmaxuelei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate (pCR + cCR) (time frame: From enrollment to postoperative pathological assessment, approximately 6 months). 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 10 Aug 2026.