Locally Advanced Rectal Cancer (LARC)Phase 1/2SG-RCTNCT07811076
Serine/Glycine-Restricted Diet With Chemoradiotherapy for Rectal Cancer
A Phase 1/2 study testing Serine/Glycine-Restricted Diet, CAPOX Chemotherapy and PD-1 Inhibitor in people with Locally Advanced Rectal Cancer (LARC), run by Xuelei Ma MD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- What is being tested?
- Serine/Glycine-Restricted Diet, CAPOX Chemotherapy and 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
- 1 siteChina
- Study dates
- 31 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
- Written informed consent obtained prior to any study-related procedures.
- Male or female, aged 18-80 years.
- Histologically confirmed locally advanced rectal cancer staged as cT3, cT4, or node-positive by pelvic MRI.
- ECOG performance status score of 0 or 1.
- NRS-2002 score < 3 (no significant nutritional risk).
- BMI ≥ 18.5 kg/m² (may be adjusted per actual conditions).
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- Capable of oral intake or via feeding tube and able to tolerate enteral nutrition.
- Adequate organ function as defined by the following laboratory criteria:
- ANC ≥ 1.5×10⁹/L (without G-CSF support within 14 days); Platelet count ≥ 100×10⁹/L; Hemoglobin ≥ 9 g/dL (without transfusion or erythropoietin use 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 (Cockcroft-Gault formula) 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 required for enrollment); Cardiac enzymes within normal range (isolated laboratory abnormalities without clinical significance permitted).
- Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to study treatment initiation and agree to use highly effective contraception from signing informed consent through at least 6 months after the last dose of study treatment.
- All patients (male or female) at risk of pregnancy must use contraceptive methods with a failure rate < 1% per year throughout the treatment period and up to 120 days after the last dose of study treatment (or 180 days after the last dose of chemotherapy).
Who cannot join
- Stage I or Stage IV rectal cancer.
- Cognitive impairment or psychiatric disorders that prevent comprehension of the study content.
- Central nervous system or meningeal metastases.
- Clinically symptomatic moderate to severe ascites (requiring therapeutic paracentesis within 2 weeks before study treatment start; patients with small asymptomatic ascites 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 (CTCAE grade ≥ 3 within 6 months or grade ≥ 2 within 3 months before study treatment start, e.g., abnormal vaginal bleeding, hematemesis).
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- Any other condition that may affect the study results or lead to forced discontinuation (e.g., alcohol abuse, drug abuse, serious concurrent diseases, severe laboratory abnormalities, family or social factors) as judged by the investigator.
- Known allergy to any active ingredient or excipient of the study drugs or nutritional powder.
- Poorly controlled diabetes mellitus.
- Severe cardiovascular disease, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or major vascular disease within 6 months prior to enrollment; uncontrolled symptomatic cardiac disease such as unstable angina, NYHA class II or higher heart failure, LVEF < 50% on echocardiography, or severe arrhythmia not controlled by medication.
- Pregnancy or lactation.
- Any other condition that the investigator considers unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Xuelei Ma, MD, 13408410416, drmaxuelei@gmail.com
Xuelei Ma, MD
About this study
Official title: A Randomized Controlled Trial of Serine/Glycine-Restricted Diet Combined With Chemoradiotherapy and Immunotherapy for Neoadjuvant Treatment of Rectal Cancer
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.
Read more
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.
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Being tested
- Serine/Glycine-Restricted Diet, CAPOX Chemotherapy, PD-1 Inhibitor, Short-Course Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serine/Glycine-Restricted DietDietary supplement
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.
CAPOX ChemotherapyDrug
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.
PD-1 InhibitorDrug
PD-1 inhibitor administered intravenously every 3 weeks in combination with CAPOX chemotherapy as part of the neoadjuvant regimen.
Short-Course RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Serine/Glycine-Restricted Diet Plus Chemoradiotherapy and Immunotherapy | Experimental | Not described Receives: Dietary Supplement: Serine/Glycine-Restricted Diet; Drug: CAPOX Chemotherapy; Drug: PD-1 Inhibitor; Radiation: Short-Course Radiotherapy |
| Chemoradiotherapy and Immunotherapy Without Dietary Restriction | Active comparator | Not described Receives: Drug: CAPOX Chemotherapy; Drug: PD-1 Inhibitor; Radiation: Short-Course Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (pCR + cCR)
Measured: At the time of surgery, approximately 6-8 weeks after completion of all 6 cycles of neoadjuvant chemoradiotherapy and immunotherapy
Secondary outcomes (10)
Major Pathological Response (MPR) Rate
Measured: At the time of radical surgery, approximately 24 weeks after initiation of neoadjuvant treatment.
R0 Resection Rate
Measured: At the time of radical surgery, approximately 24 weeks after initiation of neoadjuvant treatment.
mrTRG Regression Grade
Measured: Up to approximately 24 weeks after initiation of neoadjuvant treatment (at the time of pre-surgery imaging assessment).
Event-Free Survival (EFS)
Measured: Up to 5 years after randomization.
Progression-Free Survival (PFS)
Measured: Up to 5 years after randomization.
Overall Survival (OS)
Measured: Up to 5 years after randomization.
Incidence of Adverse Events
Measured: From the start of study treatment through 30 days after the last dose of study treatment (approximately up to 22 weeks for the active treatment phase).
Changes in Serum Amino Acid Levels
Measured: Baseline and at cycles 1, 2, and 3 (weeks 3, 6, and 9) during the intervention phase.
Quality of Life (EORTC QLQ-C30)
Measured: Baseline, at cycles 1, 2, 3, 4, 5, 6 (weeks 3, 6, 9, 12, 15, 18), and at 30-day safety follow-up.
Nutritional Status
Measured: Baseline, at cycles 1, 2, and 3 (weeks 3, 6, and 9), and at surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Jan 2027 (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 Locally Advanced Rectal Cancer (LARC)Studies 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
- 140 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
- NCT07811076
- Sponsor's protocol ID
- Approval No. 1280 (2026)
- Acronym
- SG-RCT
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Serine/Glycine-Restricted Diet Combined With Chemoradiotherapy and Immunotherapy for Neoadjuvant Treatment of Rectal Cancer
- ClinicalTrials.gov ID
- NCT07811076
- Acronym / sponsor ID
- SG-RCT / Approval No. 1280 (2026)
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Xuelei Ma MDUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 9 Sep 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serine/Glycine-Restricted Diet Plus Chemoradiotherapy and Immunotherapy | Experimental | Dietary Supplement: Serine/Glycine-Restricted Diet, Drug: CAPOX Chemotherapy, Drug: PD-1 Inhibitor, Radiation: Short-Course Radiotherapy |
| Chemoradiotherapy and Immunotherapy Without Dietary Restriction | Active comparator | Drug: CAPOX Chemotherapy, Drug: PD-1 Inhibitor, Radiation: Short-Course Radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent obtained prior to any study-related procedures.
- Male or female, aged 18-80 years.
- Histologically confirmed locally advanced rectal cancer staged as cT3, cT4, or node-positive by pelvic MRI.
- ECOG performance status score of 0 or 1.
- NRS-2002 score < 3 (no significant nutritional risk).
Key exclusion criteria (12 listed)
- Stage I or Stage IV rectal cancer.
- Cognitive impairment or psychiatric disorders that prevent comprehension of the study content.
- Central nervous system or meningeal metastases.
- Clinically symptomatic moderate to severe ascites (requiring therapeutic paracentesis within 2 weeks before study treatment start; patients with small asymptomatic ascites 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 |
|---|---|---|
| Serine/Glycine-Restricted DietA 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. | Dietary supplement | Serine/Glycine-Restricted Diet Plus Chemoradiotherapy and Immunotherapy |
| CAPOX ChemotherapyOxaliplatin 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 | Chemoradiotherapy and Immunotherapy Without Dietary Restriction, Serine/Glycine-Restricted Diet Plus Chemoradiotherapy and Immunotherapy |
| PD-1 InhibitorPD-1 inhibitor administered intravenously every 3 weeks in combination with CAPOX chemotherapy as part of the neoadjuvant regimen. | Drug | Chemoradiotherapy and Immunotherapy Without Dietary Restriction, Serine/Glycine-Restricted Diet Plus Chemoradiotherapy and Immunotherapy |
| Short-Course Radiotherapy25 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. | Radiation | Chemoradiotherapy and Immunotherapy Without Dietary Restriction, Serine/Glycine-Restricted Diet Plus Chemoradiotherapy and Immunotherapy |
Primary outcome
Complete Response Rate (pCR + cCR)
Time frame: At the time of surgery, approximately 6-8 weeks after completion of all 6 cycles of neoadjuvant chemoradiotherapy and immunotherapy
10 secondary outcomes
Major Pathological Response (MPR) Rate
Time frame: At the time of radical surgery, approximately 24 weeks after initiation of neoadjuvant treatment.
R0 Resection Rate
Time frame: At the time of radical surgery, approximately 24 weeks after initiation of neoadjuvant treatment.
mrTRG Regression Grade
Time frame: Up to approximately 24 weeks after initiation of neoadjuvant treatment (at the time of pre-surgery imaging assessment).
Event-Free Survival (EFS)
Time frame: Up to 5 years after randomization.
Progression-Free Survival (PFS)
Time frame: Up to 5 years after randomization.
Overall Survival (OS)
Time frame: Up to 5 years after randomization.
Incidence of Adverse Events
Time frame: From the start of study treatment through 30 days after the last dose of study treatment (approximately up to 22 weeks for the active treatment phase).
Changes in Serum Amino Acid Levels
Time frame: Baseline and at cycles 1, 2, and 3 (weeks 3, 6, and 9) during the intervention phase.
Quality of Life (EORTC QLQ-C30)
Time frame: Baseline, at cycles 1, 2, 3, 4, 5, 6 (weeks 3, 6, 9, 12, 15, 18), and at 30-day safety follow-up.
Nutritional Status
Time frame: Baseline, at cycles 1, 2, and 3 (weeks 3, 6, and 9), and at surgery.
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 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Serine/Glycine-Restricted Diet, CAPOX Chemotherapy and PD-1 Inhibitor in people with Locally Advanced Rectal Cancer (LARC), run by Xuelei Ma MD at 1 site in China.
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 11 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (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 Rate (pCR + cCR) (time frame: At the time of surgery, approximately 6-8 weeks after completion of all 6 cycles of neoadjuvant chemoradiotherapy and immunotherapy). 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 9 Sep 2026.