Combining short radiation with immunotherapy and chemotherapy for rectal cancer treatment

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

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: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sir Run Run Shaw Hospital (other)
• Drugs / interventions: Adebrelimab, immunotherapy, prednisone, radiation, chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06266832 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: While the combination of immunotherapy and radiation is a novel approach, similar studies have shown promising results in enhancing treatment efficacy for various cancers.

Eligibility 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 this trial is running

Hangzhou, Zhejiang

• 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

Conditions: Rectal Adenocarcinoma