A Phase 2 interventional study of Short-Course Radiotherapy and PD-1 monoclonal antibody in Rectal Adenocarcinoma, High-Risk Cancer and MSS, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Phase 2, Interventional, and Treatment
Among 41 studies in Rectal Neoplasms by Sixth Affiliated Hospital, Sun Yat-sen University — 27 open to participants now, 27 under way, 3 of them phase 3. Rectal Neoplasms · Sixth Affiliated Hospital, Sun Yat-sen University.
Among the 41 studies in Rectal Neoplasms by Sixth Affiliated Hospital, Sun Yat-sen University, this one is the 13th largest by planned enrollment of the 26 interventional ones that give a count, is one of 6 that started in 2026, is one of 13 in phase 2, reaches primary completion later than 24 of the 26 other live ones, and was the 40th registered.
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
Browse Rectal Neoplasms studies →27 of the 41 studies in Rectal Neoplasms by Sixth Affiliated Hospital, Sun Yat-sen University are open now, in 1 country. Recruiting first, the newest first:
Sixth Affiliated Hospital, Sun Yat-sen University · Sites in China
Ages 18–75
Sixth Affiliated Hospital, Sun Yat-sen University · Sites in China
Ages 18–75
Sixth Affiliated Hospital, Sun Yat-sen University · Sites in China
Ages 18–75
Sixth Affiliated Hospital, Sun Yat-sen University · Sites in China
Ages 18–75
Sixth Affiliated Hospital, Sun Yat-sen University · Sites in China
Ages 18–75
By country, each count listing its studies:
Of the 404 Rectal Neoplasms studies recruiting now, 210 (52%) set no upper age limit and 142 (35%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 14 · Phase 3 3
First in 2012; this study’s year is marked. 6 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.
Median enrollment 100 across the 26 interventional studies, 200 across the 15 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 217 studies on the registry; 111 are open to participants now.
7 of the studies in Rectal Neoplasms by Sixth Affiliated Hospital, Sun Yat-sen University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07297004Sixth Affiliated Hospital, Sun Yat-sen UniversityStereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer | 2026-11-30 |
| NCT06767007Sixth Affiliated Hospital, Sun Yat-sen UniversitySBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer（SPARKLE） | 2026-11-30 |
| NCT05523245Sixth Affiliated Hospital, Sun Yat-sen UniversityPredicting the Efficacy of Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer Using an AI Platform Based on Multi-parametric MRI | 2026-12 |
| NCT04643041Sixth Affiliated Hospital, Sun Yat-sen UniversityWatch and Wait in PD-1 Monoclonal Antibody Treated dMMR/MSI-H Distal Rectal Cancer | 2026-12-31 |
| NCT07154173Sixth Affiliated Hospital, Sun Yat-sen UniversityComprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer | 2026-12-31 |
Add all 7 to your calendar (.ics) → With an account.
Among the 41 studies in Rectal Neoplasms by Sixth Affiliated Hospital, Sun Yat-sen University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
To explore the efficacy and safety of adding a ketogenic diet and/or high-dose intravenous vitamin C to neoadjuvant short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with serplulimab in patients with locally advanced pMMR/MSS rectal adenocarcinoma through a prospective, randomized, controlled phase II clinical study, providing preliminary evidence for optimizing neoadjuvant treatment strategies for this population.
Patients with locally advanced rectal adenocarcinoma characterized by proficient mismatch repair or microsatellite stability (pMMR/MSS) generally derive limited benefit from immune checkpoint inhibitor monotherapy. Metabolic interventions may enhance the efficacy of chemotherapy and immunotherapy by modulating tumor metabolism and the tumor immune microenvironment. High-dose vitamin C has multitarget antitumor effects. Preclinical evidence suggests that it may activate the AMPK pathway, downregulate PD-L1 expression in colorectal cancer cells, and promote T-cell infiltration into the tumor microenvironment, thereby providing a mechanistic rationale for its combination with PD-1 blockade. In the phase III VITALITY trial, high-dose intravenous vitamin C combined with chemotherapy did not significantly improve progression-free survival in the overall population with metastatic colorectal cancer; however, a prespecified subgroup analysis demonstrated prolonged progression-free survival among patients with RAS-mutant tumors. A ketogenic diet may also exert antitumor effects by altering glucose availability, cellular energy metabolism, and the immune microenvironment. Emerging evidence suggests that dietary patterns, including high-fiber diets in patients receiving immunotherapy and ketogenic diets in those receiving chemotherapy, may be associated with improved treatment responses, although these findings require prospective validation. Therefore, this study aims to investigate whether adding a ketogenic diet and/or high-dose intravenous vitamin C to short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with the PD-1 monoclonal antibody serplulimab can improve the pathological complete response and organ preservation rates in patients with locally advanced pMMR/MSS rectal adenocarcinoma. The efficacy and safety of four treatment strategies-no metabolic intervention, a ketogenic diet alone, high-dose intravenous vitamin C alone, and their combination-will be evaluated.
Inclusion Criteria:
1. confirmed rectal adenocarcinoma. 2. Age 18-80 years. 3. Immunohistochemical examination of 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 , 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. (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:
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-L1, anti-PD-L2, or anti-CTLA-4 antibodies), or other agents.
12. Not pregnant or breastfeeding. Participants must use effective during the study and for 6 months after the final dose of study treatment.
13. Written has been provided. Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with 6 cycles of the mFOLFOX6 regimen and PD-1 monoclonal antibody. Initially, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients complete 6 cycles of mFOLFOX6 chemotherapy combined with PD-1 monoclonal antibody at two-week intervals. Surgery is performed 2 weeks after the completion of the last cycle of chemotherapy.
Radiation: Short-Course Radiotherapy · Drug: PD-1 monoclonal antibody · Combination Product: mFOLFOX6 regimen · Procedure: Surgical resection
The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with 6 cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody and daily ketogenic diet. Initially, patients undergo SCRT at a dose of 5Gy × 5 fractions. After completing radiotherapy, patients initiate a ketogenic dietary intervention and, at least 7 days later, receive six cycles of mFOLFOX6 chemotherapy combined with a PD-1 monoclonal antibody at two-week intervals. The ketogenic dietary intervention continues until the completion of neoadjuvant treatment. Surgery is performed 2 weeks after the completion of the last cycle of chemotherapy.
Radiation: Short-Course Radiotherapy · Drug: PD-1 monoclonal antibody · Combination Product: mFOLFOX6 regimen · Behavioral: Ketogenic Diet · Procedure: Surgical resection
The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with 6 cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody and Vitamin C. Initially, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients complete 6 cycles of mFOLFOX6 chemotherapy combined with PD-1 monoclonal antibody and at two-week intervals, together with intravenous vitamin C at 1.5 g/kg/day on three consecutive days (Days 1-3) of each cycle. Surgery is performed 2 weeks after the completion of the last cycle of chemotherapy.
Radiation: Short-Course Radiotherapy · Drug: PD-1 monoclonal antibody · Combination Product: mFOLFOX6 regimen · Procedure: Surgical resection · Drug: Vitamin C
The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with 6 cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody, Vitamin C and daily ketogenic diet. Initially, patients undergo SCRT at a dose of 5Gy × 5 fractions. After completing radiotherapy, patients initiate a ketogenic dietary intervention and, at least 7 days later, receive six cycles of mFOLFOX6 chemotherapy combined with a PD-1 monoclonal antibody at two-week intervals, together with intravenous vitamin C at 1.5 g/kg/day on three consecutive days (Days 1-3) of each cycle. The ketogenic dietary intervention continues until the completion of neoadjuvant treatment. Surgery is performed 2 weeks after the completion of the last cycle of chemotherapy.
Radiation: Short-Course Radiotherapy · Drug: PD-1 monoclonal antibody · Combination Product: mFOLFOX6 regimen · Behavioral: Ketogenic Diet · Procedure: Surgical resection · Drug: Vitamin C
Patients undergo SCRT at a dose of 5Gy × 5 fractions
Also known as: SCRT
Patients receive six cycles of immunotherapy with serplulimab injection, a PD-1 monoclonal antibody, at a fixed dose of 200 mg per cycle.
Also known as: PD-1
Patients receive six cycles of the mFOLFOX6 regimen, consisting of oxaliplatin (85 mg/m²) and leucovorin (200 mg/m²) administered intravenously over 2 hours, followed by a bolus of fluorouracil (400 mg/m²) and a continuous infusion of fluorouracil (2,400 mg/m²) over 46 hours.
Also known as: mFOLFOX6
A modified Atkins diet (MAD) is used, with the goal of maintaining nutritional ketosis, defined as a blood β-hydroxybutyrate (BHB) level of 1.5-3.0 mmol/L. The ketogenic dietary intervention begins after completion of SCRT and continues throughout six cycles of mFOLFOX6 chemotherapy and immunotherapy until the completion of neoadjuvant treatment.
Also known as: Modified Atkins Diet
Surgery either local excition or total mesorectal excision is performed 2 weeks after the completion of neoadjuvant therapy.
Also known as: Surgery
Vitamin C is administered intravenously at a dose of 1.5 g/kg/day, diluted in 250-500 mL of normal saline, over 2 hours for 3 consecutive days (Days 1-3). Each treatment cycle is repeated every 2 weeks and synchronized with the neoadjuvant treatment cycle.
Also known as: VitC
pCR rate
Pathological complete response rate, ypT0N0 for TME surgery and ypT0rN0 for local excision
Time frame: 1 year
Adverse Events Associated with Neoadjuvant Therapy
Incidence of adverse events related to neoadjuvant therapy as assessed by CTCAE v5.0
Time frame: 1 year
MPR
Major pathological response rate
Time frame: 1 year
Neoadjuvant therapy completion rate Neoadjuvant therapy completion rate Neoadjuvant therapy completion rate Neoadjuvant therapy completion rate
Completion rate of neoadjuvant therapy
Time frame: 1 year
R0 resection rate
R0 resection rate in participants
Time frame: 1 year
TRG
Tumor regression grade
Time frame: 1 year
3 years DFS Rate
3 years Disease Free Survival Rate
Time frame: 3 years
3 years OS rate
3 years Overall Survival Rate
Time frame: 3 years
Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.
Of 227 non-industry phase 2 interventional studies under Rectal Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 80. This study's planned 36 months is below that.
Counting every sponsor, half of 241 studies reached it within 46 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Ascorbic Acid
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