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Trial Title:
Nodes-sparing Short-course Radiation Combined With CAPOX and Tislelizumab for MSS Middle and Low Rectal Cancer
NCT ID:
NCT05972655
Condition:
Low Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Oxaliplatin
Antibodies
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:
Radiation
Intervention name:
Modified short-course radiotherapy
Description:
radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph
nodes: 25Gy/5Fx
Arm group label:
Treatment Arm
Intervention type:
Drug
Intervention name:
PD-1 antibody
Description:
PD-1 antibody (Tislelizumab): 200mg d1 q3w
Arm group label:
Treatment Arm
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine: 1000mg/m2 d1-14 q3w
Arm group label:
Treatment Arm
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin: 130mg/m2 d1 q3w
Arm group label:
Treatment Arm
Summary:
This is an open-label, prospective, multicenter phase II clinical trial to evaluate
modified short-course radiation (Radiation targeting the tumor bed without irradiating
surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor
(Tislelizumab) for patients with MSS middle and low rectal cancer. A total of 32 patients
will be enrolled in this trial. The primary endpoint is the rate of pathological complete
response (pCR). The organ preservation rate, tumor regression grade, long-term prognosis,
and adverse effects will also be analyzed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients who have a strong willingness to preserve the anus and are willing to
receive neoadjuvant therapy.
2. Male or Female aged 18-75.
3. Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the
tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is
cT2N+M0/cT3-4aN0/+M0, the lymph nodes are limited to the mesorectum, the
circumferential resection margin is negative.
4. Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or
MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6,
and PMS2 are all positive.
5. Eastern Cooperative Oncology Group (ECOG) 0-1.
6. No previous treatment(including anti-tumor therapy、immunotherapy or pelvic
radiation).
7. Adequate hematologic, hepatic, renal, thyroid and cardiac function: white blood
cells ≥3500/mm3, neutrophils ≥1800/mm3, platelets ≥100,000/mm3, hemoglobin ≥100 g/L;
activated partial thromboplastin time, prothrombin time and international normalized
ratio ≤1.5 × ULN; aspartate aminotransferase and alanine aminotransferase ≤3.0 ×
upper limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g/L.
creatinine clearance ≥50 mL/mi, creatinine ≤1.5 × ULN;
8. Informed consent form signed.
Exclusion Criteria:
1. Patients with a previous history of malignant tumors besides rectal cancer.
2. Patients with distant metastases before enrollment.
3. Patients with positive internal or external iliac lymph nodes are assessed by MRI or
CT.
4. Patients with obstruction, perforation, or bleeding that require emergency surgery.
5. Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
6. Allergic to any component of the therapy.
7. Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, or
mucinous adenocarcinoma.
8. Patients who received immunosuppressive or systemic hormone therapy for
immunosuppressive purposes within 1 month prior to the initiation of therapy.
9. Patients who have received any other experimental drug (including immunotherapy) or
participated in another interventional clinical trial within 30 days before
screening.
10. Factors leading to study termination, such as alcoholism, drug abuse, other serious
illnesses (including psychiatric disorders) requiring combination therapy, and
patients with severe laboratory abnormalities.
11. Patients with congenital or acquired immune deficiency (such as HIV infection).
12. Vulnerable groups, including mentally ill, cognitively impaired, critically ill
patients, minors, pregnant or lactating women, illiterate, etc.
13. Other conditions that investigators consider not suitable for this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sir Run Run Shao hospital
Address:
City:
Hanzhou
Zip:
310012
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhangfa Song, Dr
Phone:
+86 13867421652
Email:
songzhangfa@zju.edu.cn
Investigator:
Last name:
Zhangfa Song, doctor
Email:
Principal Investigator
Start date:
August 2, 2023
Completion date:
May 1, 2026
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/NCT05972655
