Can diet and vitamin c supercharge rectal cancer treatment?
NCT ID NCT07765667
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This phase 2 trial is investigating whether adding a ketogenic diet and/or high-dose intravenous vitamin C to standard chemoradiotherapy and immunotherapy can improve outcomes for patients with locally advanced rectal cancer that is mismatch repair proficient (pMMR/MSS). The study will enroll 100 adults aged 18-80 with this specific type of rectal cancer. Participants will receive standard short-course radiation, chemotherapy, and an immunotherapy drug called serplulimab, with some also following a ketogenic diet or receiving vitamin C infusions. The main goal is to see if these additions increase the rate of a complete pathological response, meaning no cancer cells remain after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of a ketogenic diet and/or high-dose intravenous vitamin C added to standard chemoradiotherapy and immunotherapy (serplulimab, a PD-1 inhibitor)
- What this could lead to
- If effective, this approach could increase the chance of a complete tumor response before surgery, potentially improving outcomes for patients with a hard-to-treat form of rectal cancer.
- What could go wrong
- This is an early-phase trial, so the added benefits are uncertain. The diet and vitamin C may not enhance treatment, and there is a risk of increased side effects from combining multiple therapies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1\. Histologically confirmed rectal adenocarcinoma. 2. Age 18-80 years. 3. Immunohistochemical examination of biopsy specimens indicating proficient mismatch repair (pMMR), or microsatellite-stable (MSS) status. 4\. Clinical stage cT3-T4N0 or cTxN+. 5. The lower margin of the rectal tumor is ≤10 cm from the anal verge. 6. No distant metastases, as confirmed by contrast-enhanced CT of the chest, abdomen, and pelvis and pelvic MRI before treatment. 7\. No evidence of intestinal obstruction, or resolution of obstruction following diverting stoma surgery. 8\. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 9. Adequate peripheral blood counts and hepatic and renal function, as defined by the following laboratory values measured within 15 days before treatment initiation: * White blood cell count (WBC) ≥3.0 × 10⁹/L or absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; * Hemoglobin (HGB) ≥80 g/L; * Platelet count (PLT) ≥100 × 10⁹/L; * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3.0 × the upper limit of normal (ULN); * Total bilirubin (TBIL) \<1.5 × ULN; * Serum creatinine (CREAT) \<1.5 × ULN. 10. No prior chemotherapy or radiotherapy. 11. No prior treatment with biological agents (e.g., monoclonal antibodies), immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies), or other investigational agents. 12\. Not pregnant or breastfeeding. Participants must use effective contraception during the study and for 6 months after the final dose of study treatment. 13\. Written informed consent has been provided. Exclusion Criteria 1. Arrhythmia requiring antiarrhythmic therapy, except for beta-blockers or digoxin; symptomatic coronary artery disease; myocardial ischemia, including myocardial infarction within the previous 6 months; or congestive heart failure greater than New York Heart Association (NYHA) class II. 2. Severe hypertension that is inadequately controlled with medication. 3. A history of human immunodeficiency virus (HIV) infection or active chronic hepatitis B or C infection with a high viral DNA copy number. 4. Active tuberculosis (TB), current anti-tuberculosis treatment, or receipt of anti-tuberculosis treatment within 1 year before screening. 5. Other active, clinically serious infections according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. 6. Preoperative evidence of distant metastases outside the pelvis. 7. Cachexia or decompensated organ function. 8. Prior pelvic or abdominal radiotherapy. 9. Multiple primary colorectal cancers. 10. Confirmed glucose-6-phosphate dehydrogenase (G6PD) deficiency. 11. Seizures requiring treatment, such as corticosteroid or antiepileptic therapy. 12. A history of another malignancy within the previous 5 years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin. 13. Substance abuse or any medical, psychological, or social condition that may interfere with participation in the study or the evaluation of study results. 14. Any active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, or hypothyroidism. Participants with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be enrolled; participants with asthma requiring medical intervention with bronchodilators are excluded. 15. Receipt of any vaccine against an infectious disease, such as an influenza or varicella vaccine, within 4 weeks before enrollment. 16. A concomitant condition requiring long-term immunosuppressive therapy or systemic or topical corticosteroids at immunosuppressive doses, defined as \>10 mg/day of prednisone or an equivalent corticosteroid. 17. Gastrointestinal disorders, such as an active gastric or duodenal ulcer, ulcerative colitis, or an unresected tumor with active bleeding; any other condition that may cause gastrointestinal bleeding or perforation; or an unhealed gastrointestinal perforation following surgery. 18. Known or suspected hypersensitivity to any study drug or to any medication administered in connection with this study. 19. Any unstable condition or other circumstance that may compromise participant safety or treatment compliance. 20. Pregnant or breastfeeding women, or women of childbearing potential who are not using adequate contraception. 21. Refusal to provide written informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New injectable drug tested against Hard-to-Treat solid tumors
- Could a nasal tube replace a temporary ileostomy after rectal cancer surgery?
- Blood test aims to catch Cancer's return earlier
- Blood test guides immunotherapy for hidden cancer cells
- Can Pre-Surgery radiation stop rectal cancer from returning?