Trial 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
NCT ID:
NCT06266832
Condition:
Rectal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Rectal Neoplasms
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
This product is administered by intravenously guttae. The recommended dose of
subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).
Arm group label:
Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX
Other name:
SHR-1316
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
130mg/m2, ivgtt, d1, Q3W
Arm group label:
Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1000mg/m2, po, bid, d1-14, Q3W
Arm group label:
Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX
Intervention type:
Radiation
Intervention name:
Short-course Radiation
Description:
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.
Arm group label:
Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
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.
Arm group label:
Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX
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.
Detailed description:
At present, neoadjuvant chemoradiotherapy (nCRT) combined with total mesorectal excision
(TME) is the main standard treatment, and the choice of treatment modalities is limited.
The emergence of immunotherapy has provided a new direction for the exploration of
neoadjuvant therapy for rectal adenocarcinoma. At the same time, a number of studies have
also shown that appropriate radiotherapy intensity can promote immune response.
Therefore, the investigators intend to conduct the clinical trail to explore the effect
of short-course radiotherapy combined with PD-L1 combined and chemotherapy as TNT (total
neoadjuvant therapy) on organ retention rate in patients with With MSS/pMMR Ultra Low
Rectal Adenocarcinoma.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiujun Cai
Start date:
January 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Sir Run Run Shaw Hospital
Agency class:
Other
Source:
Sir Run Run Shaw Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06266832
