Locally Advanced Rectal CancerPhase 1/2SG-RCTNCT07912463
Phase Ib/II Trial of Serine/Glycine-Restricted Diet With Chemoradiotherapy for Rectal Cancer
A Phase 1/2 study testing Serine/Glycine-Restricted Diet, CAPOX Chemotherapy and Long-Course Radiotherapy in people with Locally Advanced Rectal Cancer, run by Xuelei Ma MD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Serine/Glycine-Restricted Diet, CAPOX Chemotherapy and Long-Course Radiotherapy
- Type of treatment
- 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
- 15 Nov 2026to 15 Nov 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 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.
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- 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.
Who cannot join
- 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).
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- 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.
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: Phase Ib/II Clinical Trial of Serine/Glycine-Restricted Diet Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer
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.
Read more
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.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Serine/Glycine-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.
Serine/Glycine-Restricted DietDietary supplement
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.
CAPOX ChemotherapyDrug
Oxaliplatin and capecitabine combination chemotherapy administered for 6 cycles as part of the standard neoadjuvant regimen.
Long-Course RadiotherapyRadiation
Pelvic radiotherapy delivered with a total dose of 45.0-50.4 Gy in 25-28 fractions, concurrent with capecitabine.
| Study group | Role | What they receive |
|---|---|---|
| Serine/Glycine-Restricted Diet Plus Chemoradiotherapy | Experimental | Not described Receives: Dietary Supplement: Serine/Glycine-Restricted Diet; Drug: CAPOX Chemotherapy; Radiation: Long-Course Radiotherapy |
| Standard Chemoradiotherapy Without Dietary Restriction | Active comparator | Not described 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 (Pathological and Clinical)
The proportion of patients achieving pathological complete response (pCR) or clinical complete response (cCR). pCR is defined as no residual tumor cells in the resected tumor and regional lymph nodes. cCR is defined as no evidence of residual tumor in the primary lesion and regional lymph nodes after neoadjuvant therapy, assessed by digital rectal examination, endoscopy, pelvic high-resolution MRI (T2WI/DWI), and serum CEA levels.
Measured: At the time of radical surgery (approximately 24 weeks after initiation of neoadjuvant treatment), or at the time of clinical evaluation for cCR (if patients opt for a Watch-and-Wait strategy).
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 start15 Nov 2026 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 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 CancerStudies 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
- NCT07912463
- Sponsor's protocol ID
- Approval No. 1646 (2026)
- Acronym
- SG-RCT
- 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
- Phase Ib/II Clinical Trial of Serine/Glycine-Restricted Diet Combined With Chemoradiotherapy for Neoadjuvant Treatment of Rectal Cancer
- ClinicalTrials.gov ID
- NCT07912463
- Acronym / sponsor ID
- SG-RCT / Approval No. 1646 (2026)
- Conditions
- Locally Advanced Rectal Cancer
- 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
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 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 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.
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 | Experimental | Dietary Supplement: Serine/Glycine-Restricted Diet, Drug: CAPOX Chemotherapy, Radiation: Long-Course Radiotherapy |
| Standard Chemoradiotherapy Without Dietary Restriction | Active comparator | Drug: CAPOX Chemotherapy, Radiation: Long-Course Radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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 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. | Dietary supplement | Serine/Glycine-Restricted Diet Plus Chemoradiotherapy |
| CAPOX ChemotherapyOxaliplatin and capecitabine combination chemotherapy administered for 6 cycles as part of the standard neoadjuvant regimen. | Drug | Serine/Glycine-Restricted Diet Plus Chemoradiotherapy, Standard Chemoradiotherapy Without Dietary Restriction |
| Long-Course RadiotherapyPelvic radiotherapy delivered with a total dose of 45.0-50.4 Gy in 25-28 fractions, concurrent with capecitabine. | Radiation | Serine/Glycine-Restricted Diet Plus Chemoradiotherapy, Standard Chemoradiotherapy Without Dietary Restriction |
Primary outcome
Rate of Complete Response (Pathological and Clinical)
Time frame: At the time of radical surgery (approximately 24 weeks after initiation of neoadjuvant treatment), or at the time of clinical evaluation for cCR (if patients opt for a Watch-and-Wait strategy).
The proportion of patients achieving pathological complete response (pCR) or clinical complete response (cCR). pCR is defined as no residual tumor cells in the resected tumor and regional lymph nodes. cCR is defined as no evidence of residual tumor in the primary lesion and regional lymph nodes after neoadjuvant therapy, assessed by digital rectal examination, endoscopy, pelvic high-resolution MRI (T2WI/DWI), and serum CEA levels.
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 Serine/Glycine-Restricted Diet, CAPOX Chemotherapy and Long-Course Radiotherapy in people with Locally Advanced Rectal Cancer, 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 (13408410416, 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 (Pathological and Clinical) (time frame: At the time of radical surgery (approximately 24 weeks after initiation of neoadjuvant treatment), or at the time of clinical evaluation for cCR (if patients opt for a Watch-and-Wait strategy).). 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.