Could a triple therapy help rectal cancer patients avoid a colostomy bag?
NCT ID NCT07397442
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
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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 19 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2033
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 75 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. 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.
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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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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
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Other studies related to the condition(s) this trial covers.
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- New drug combo aims to shrink rectal tumors before surgery
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- Gut bacteria boost? new trial combines probiotic with cancer therapy for rectal tumors