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

Gå till den engelska sidan

Could a triple therapy help rectal cancer patients avoid a colostomy bag?

NCT ID NCT07397442

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase II trial tests a new combination of short-course radiation, two immunotherapy drugs (Qibei'an and Camrelizumab), and chemotherapy (XELOX) in 19 people with locally advanced rectal cancer. The goal is to see if this approach can make the tumor disappear completely, allowing patients to avoid permanent colostomy. All participants receive the experimental treatment, and they will be followed for up to 5 years.

What this could mean

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

Active substance
Short-course radiotherapy, Qibei'an (iparolizumab-tovorilimab), Camrelizumab, and XELOX chemotherapy (oxaliplatin + capecitabine)
What this could lead to
If successful, this combination could help more people with rectal cancer avoid permanent colostomy bags by making the tumor disappear completely before surgery.
What could go wrong
This is a very early, small study with only 19 people, so results may not apply to everyone. The combination of radiation, chemo, and immunotherapy may cause significant side effects.

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 19 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Feb 2033

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. Age 18-75 years. 2. ECOG performance status score 0-2. 3. Rectal adenocarcinoma confirmed by colonoscopic pathology, with pMMR or MSS. 4. Imaging studies confirm no distant metastasis or lateral lymph node metastasis; MRI staging is II/III (excluding T4b, N1c, N2) and any positive lymph nodes (if present) are confined within the mesorectum. 5. MRI shows the distal margin of the tumor is ≤10 cm from the anal verge, and the mesorectal fascia (MRF) is negative. 6. The longest diameter of the rectal cancer lesion is ≥10 mm on baseline CT or MRI (meeting the definition of a "measurable lesion" per RECIST 1.1 criteria). 7. Willing and able to comply with the study procedures. 8. Consent to the use of tissue and blood samples by the investigator for medical research purposes. 9. No prior history of radiotherapy or immunotherapy. 10. No history of immune system diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, ulcerative colitis, HIV infection, etc.). 11. No history of endocrine system diseases (e.g., hyperthyroidism, hypothyroidism, thyroid nodules, thyroiditis, type 1 diabetes, type 2 diabetes, gestational diabetes, other specific types of diabetes, Cushing's syndrome, primary aldosteronism, pheochromocytoma, adrenal insufficiency, pituitary adenoma, anterior pituitary hypofunction, acromegaly, gigantism, polycystic ovary syndrome, precocious puberty, hypogonadism, hyperparathyroidism, hypoparathyroidism, etc.). 12. No severe cardiac, pulmonary, hepatic, or renal dysfunction. 13. No jaundice or gastrointestinal obstruction. 14. No concurrent acute infection. 15. Subjects must undergo all required baseline laboratory assessments, and results must be obtained within 1 week before enrollment. Laboratory values must meet the following criteria (per CTCAE 5.0): 1. White blood cell count ≥2000/μL. 2. Neutrophil count ≥1500/μL. 3. Platelet count ≥100×10³/μL. 4. Hemoglobin ≥9.0 g/dL. 5. Creatinine: serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance \>50 mL/min (calculated using the Cockcroft-Gault formula). 6. Creatinine clearance for females = \[140 - age (years)\] × weight (kg) × 0.85 ÷ \[72 × serum creatinine (mg/dL)\]. 7. Creatinine clearance for males = \[140 - age (years)\] × weight (kg) × 1.00 ÷ \[72 × serum creatinine (mg/dL)\]. 8. Aspartate aminotransferase (AST) ≤3 × ULN, alanine aminotransferase (ALT) ≤3 × ULN, total bilirubin ≤1.5 × ULN. 16. No psychiatric/psychological disorders affecting social functioning. 17. Women of childbearing potential must have a negative serum pregnancy test (blood HCG) within 1 week before enrollment. 18. Women of childbearing potential and men who are sexually active with women of childbearing potential must agree to use appropriate contraceptive methods. Exclusion Criteria: 1. Multifocal cancer, or concomitant other malignant tumors. 2. Received any anti-tumor therapy for other malignant tumors within the past 5 years. 3. Underwent major surgery recently (within 6 months). 4. Presence of multiple factors affecting oral drug absorption (e.g., inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.). 5. Any uncontrolled, severe comorbid diseases. 6. Allergy to any component of the study medication. 7. Life expectancy less than 5 years for any reason. 8. Planning to undergo or previously underwent organ/bone marrow transplantation. 9. Received immunosuppressive agents or glucocorticoid therapy aimed at suppressing immune responses within 1 month before enrollment. 10. For patients with a history of central nervous system diseases, the investigator will determine whether their current condition allows them to provide informed consent or comply with the study procedures, and subsequently decide whether they can be enrolled. 11. Other diseases or conditions that may prevent completion of the study treatment (e.g., alcoholism, drug addiction, etc.). 12. Pregnant or lactating women.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Rectal cancer stage II 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 places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

More trials for these conditions

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