Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06266832

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

Led by Sir Run Run Shaw Hospital · Updated on 2024-02-20

30

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma.

CONDITIONS

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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.

Not Eligible

You will not qualify if you...

  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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310016

Actively Recruiting

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Research Team

S

sheng dai, MD&PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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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 | DecenTrialz