RecruitingPhase 2NCT06266832

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

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

Sponsor

Sir Run Run Shaw Hospital

Enrollment

30 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Rectal Adenocarcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria15

Patients who are willing to receive neoadjuvant therapy.
≧18 years old.
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.
Histologically diagnosed as rectal adenocarcinoma.
MMR protein detection or MSI gene detection of rectal cancer specimens confirmed pMMR or MSS before treatment .
The clinical staging by pelvic contrast-enhanced CT and pelvic high-resolution MRI were stage I, II and III.
The patient has good compliance and can come to the hospital for re-examination as required.
ECOG Scale of Performance Status score 0-1 point.
Have not received anti-tumor and immunotherapy before enrollment.
Laboratory inspections must meet the following standards:
White blood cell count\>3.5×109/L, absolute value of neutrophils\>1.8×109/L, platelet count ≥75×109/L, hemoglobin ≥100g/L;
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;
Total bilirubin ≤ 1.25 times the upper limit of normal; ALT and AST \< 5 times the upper limit of normal;
h creatinine clearance \>50mL/min or serum creatinine \<1.5 times the upper limit of normal.
Voluntarily participate in this study and sign the informed consent.

Exclusion Criteria17

History of other malignant diseases other than rectal cancer in the past 5 years.
Patients with metastases from other sites (stage IV patients).
Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
Known allergic to oxaliplatin, capecitabine, Adebrelimab and other drugs.
Pathologically suggested signet ring cell carcinoma and mucinous adenocarcinoma.
dMMR or MSI-H patients.
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.
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.
Active autoimmune disease that may worsen while receiving immunostimulants.
Known history of positive HIV test or known acquired immunodeficiency syndrome.
Patients who are using immunosuppressive agents, except for the following conditions:
Intranasal, inhaled, topical steroids, or topical steroid injections (eg, intra-articular injections);
Physiological doses of systemic corticosteroids ≤10 mg/day prednisone or equivalent; 3) Steroids used to prevent allergic reactions (eg, before CT scan).
Received any other experimental drug treatment or participated in another interventional clinical trial within 30 days before screening.
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.
Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, etc.
Other conditions that the investigator judges that the patient is not suitable to participate in the clinical study, etc.

Interventions

DRUGAdebrelimab

This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).

DRUGOxaliplatin

130mg/m2, ivgtt, d1, Q3W

DRUGCapecitabine

1000mg/m2, po, bid, d1-14, Q3W

RADIATIONShort-course Radiation

Short-course radiotherapy, using three-dimensional conformal or intensity-modulated radiotherapy, the dose is divided into 5Gy/f, the total dose is 25Gy/5f, 1f/d, and the irradiation is completed within 7 days.

PROCEDUREBiopsy

local excision or TME surgery (total mesorectal excision) Biopsy can choose endoscopic or needle biopsy, colcal excision refers to excison of the local lession after total neoadjuvant therapy. The total mesorectal excision can choose open, laparoscopic or robotic according to the specific condition of the patient.