Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a 16-Hour fast supercharge immunotherapy against rectal cancer?

NCT ID NCT07779694

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This phase II trial is testing whether a 16-hour fast before each dose of the immunotherapy drug serplulimab, combined with chemotherapy, can improve outcomes for people with a common type of locally advanced rectal cancer. The approach aims to boost the immune system's ability to kill cancer cells, potentially increasing the chance of a complete response and avoiding the need for radiation therapy. The study enrolls adults aged 18-75 with pMMR/MSS rectal cancer that is likely removable by surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
16-hour fasting combined with serplulimab (PD-1 inhibitor) and CAPEOX chemotherapy (oxaliplatin and capecitabine)
What this could lead to
If successful, this could offer a radiation-free treatment option for rectal cancer that is more effective than chemo alone, potentially improving complete response rates and quality of life.
What could go wrong
This is a small, early-phase trial, and the combination may not improve outcomes or could cause side effects from the drugs or fasting. Results may not apply to all patients.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 51 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. Male or female subjects ≧ 18 years ≦ 75 of age. 3. Histological or cytological documentation of adenocarcinoma of the rectum. 4. No previous any systemic anticancer therapy for rectal cancer disease. 5. The primary rectal tumor is assessed as likely to be R0 resectable by a multidisciplinary colorectal cancer collaborative team, comprising at least 2 gastrointestinal surgeons and 1 radiologist. 6. The lower margin of the tumor is less than 10cm from the anus verge. 7. cT2N1-2M0, cT3N0-2M0, cT4N0-1M0 MSS with MRF(-) assessed by MRI. 8. Primary tumor can be detected by CT or MRI. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 10. Eligible tumor tissues were identified for MSI/MMR assays. 11. Hepatitis B Surface Antigen (HBsAg) (-). 12. If HBsAg (+) , HBV-DNA must be less than 2500 copies/mL or 500 IU/mL to be enrolled. 13. Patients with HCV antibody (-) or HCV-RNA negative can be enrolled. Aspartate aminotransferase (AST) must be ≤ 3 x ULN for the lab. If HCV-RNA is positive, patients with both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) performed ≤3×ULN could be enrolled. Patients infected with both hepatitis B virus and hepatitis C virus should be excluded (positive for HBsAg or HBcAb and positive for HCV antibodies). Exclusion Criteria: 1. Patients with recurrent rectal cancer or a history of pelvic radiotherapy. 2. Patients with a history of inflammatory bowel disease. 3. Patients with acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease (HIV1 antibody, HIV2 antibody, HTLV1 antibody positive) should be excluded. 4. Patients who are preparing for or have previously received an organ or bone marrow transplant. 5. History of myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms in women) in the 6 months prior to enrollment (QTc interval calculated by Fridericia formula). 6. According to New York College of Cardiology (NYHA) standards for Grade III-IV cardiac insufficiency or cardiac color ultrasound: left ventricular ejection fraction (LVEF) \<50%.Poor hypertension control (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy. 7. Poor hypertension control (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy. 8. Patients had undergone major surgery within 28 days prior to enrollment. Patients with tumor biopsy or lymph node dissection biopsy were admitted. Patients undergoing enterostomy due to intestinal obstruction were admitted. 9. The patients had previously been treated with other antibodies/drugs that target immune checkpoints, such as PD-1, PD-L1, and cytotoxic T lymphocyte-associated Antigen 4 (CTLA-4). 10. Patients are participating in other clinical studies, or plan to start this study treatment less than 14 days from the end of the previous clinical study. 11. Uncontrolled tumor-related pain. 12. A known history of severe allergy to any monoclonal antibody. 13. Known to be allergic or intolerance to any oxaliplatin and capecitabine ingredients. 14. Pregnant or lactating women. 15. The investigators determined that the patient had other factors that might have led to the early termination of the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Fasting, intermittent are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.