Combining short radiation with immunotherapy and chemotherapy for rectal cancer treatment
Official title: The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma: A Prospective, Single-arm Study
Run by Sir Run Run Shaw Hospital · NCT06266832 · Data updated 2026-11-12
This study is testing a new treatment for patients with a specific type of rectal cancer that combines short radiation, immunotherapy, and chemotherapy to see if it can help keep their organs and reduce the need for surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Sir Run Run Shaw Hospital Academic / other |
| Drugs / interventions | Adebrelimab, immunotherapy, prednisone, radiation, chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | January 1, 2025 |
| Study ends | December 31, 2027 |
| Registry record updated | February 20, 2024 |
| Trial ID | NCT06266832 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older diagnosed with MSS/pMMR ultra low rectal adenocarcinoma who have not previously received anti-tumor or immunotherapy.
✕Probably not a fit
Patients with advanced rectal cancer requiring immediate surgical intervention or those who have received prior anti-tumor therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy and safety of a new treatment approach for patients with MSS/pMMR ultra low rectal adenocarcinoma. It combines short-course radiation therapy with Adebrelimab, an immunotherapy agent, and CAPEOX chemotherapy as a neoadjuvant treatment. The goal is to improve organ retention rates while minimizing the need for surgical intervention. Participants will undergo a series of assessments to determine the effectiveness of this combined therapy compared to standard treatment options.
Why it matters
Potential benefit: If successful, this approach could enhance organ preservation and improve treatment outcomes for patients with rectal adenocarcinoma.
How similar studies have gone: While the combination of immunotherapy and radiation is a novel approach, similar studies have shown promising results in enhancing treatment efficacy for various cancers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Patients who are willing to receive neoadjuvant therapy.
2. ≧18 years old.
3. Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 5 cm from the anus.
4. Histologically diagnosed as rectal adenocarcinoma.
5. MMR protein detection or MSI gene detection of rectal cancer specimens confirmed pMMR or MSS before treatment .
6. The clinical staging by pelvic contrast-enhanced CT and pelvic high-resolution MRI were stage I, II and III.
7. The patient has good compliance and can come to the hospital for re-examination as required.
8. ECOG Scale of Performance Status score 0-1 point.
9. Have not received anti-tumor and immunotherapy before enrollment.
10. Laboratory inspections must meet the following standards:
1. White blood cell count\>3.5×109/L, absolute value of neutrophils\>1.8×109/L, platelet count ≥75×109/L, hemoglobin ≥100g/L;
2. INR≤1.5, and APTT≤1.5 times the upper limit of normal or partial prothrombin time (PT) ≤1.5 times the upper limit of normal;
3. Total bilirubin ≤ 1.25 times the upper limit of normal; ALT and AST \< 5 times the upper limit of normal;
4. 24h creatinine clearance \>50mL/min or serum creatinine \<1.5 times the upper limit of normal.
11. Voluntarily participate in this study and sign the informed consent.
Exclusion Criteria:
1. History of other malignant diseases other than rectal cancer in the past 5 years.
2. Patients with metastases from other sites (stage IV patients).
3. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
4. Known allergic to oxaliplatin, capecitabine, Adebrelimab and other drugs.
5. Pathologically suggested signet ring cell carcinoma and mucinous adenocarcinoma.
6. dMMR or MSI-H patients.
7. The patient is accompanied by any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, hypertension uncontrolled by medication, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial Infarction, congestive heart failure, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease; disease affecting the patient's life.
8. The disease (such as mental illness, etc.) or condition (such as alcoholism or drug abuse, etc.) associated with the patient will increase the risk of the patient receiving the trial drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results.
9. Active autoimmune disease that may worsen while receiving immunostimulants.
10. Known history of positive HIV test or known acquired immunodeficiency syndrome.
11. Patients who are using immunosuppressive agents, except for the following conditions:
1. Intranasal, inhaled, topical steroids, or topical steroid injections (eg, intra-articular injections);
2. Physiological doses of systemic corticosteroids ≤10 mg/day prednisone or equivalent; 3) Steroids used to prevent allergic reactions (eg, before CT scan).
12. Received any other experimental drug treatment or participated in another interventional clinical trial within 30 days before screening.
13. Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period; men or women who are unwilling to take effective contraceptive measures.
14. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, etc.
15. Other conditions that the investigator judges that the patient is not suitable to participate in the clinical study, etc.
Where it's running
-
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: sheng dai, MD&PhD — China, Zhejiang Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
- Study coordinator: sheng dai, MD&PhD
- Email: daimd@zju.edu.cn
- Phone: 13575472669
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This early-phase trial tests whether adding propranolol to adebrelimab plus platinum chemotherapy is safe and may help treat small cell lung cancer in adults.
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HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC
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This trial tests whether the combo of SHR-7787 and SHR-1316 can help adults with unresectable limited-stage small cell lung cancer after prior platinum-based chemo and radiation.
-
Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC
This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.
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A combination therapy for advanced second-line gastric cancer using apatinib with albumin-bound paclitaxel, with or without adebrelimab
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.