Trial Title:
Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer
NCT ID:
NCT06204094
Condition:
Locally Advanced Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Oxaliplatin
Conditions: Keywords:
rectal cancer
microsatellite stability
node-sparing
CAPOX
radiotherapy
sintilimab
immunotherapy
neoadjuvant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Radiation: node-sparing short-course radiotherapy (5Gy*5d) Drug: PD-1 antibody
(Sintilimab) Drug: Capecitabine Drug: Oxaliplatin
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
node-sparing short-course radiotherapy
Description:
5Gy*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining
lymph nodes
Arm group label:
Treatment Arm
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
200mg intravenous infusion d1 of each cycle*8cycles
Arm group label:
Treatment Arm
Other name:
IBI308
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1000mg/m2, PO, BID, d1-14 of each cycle*8cycles
Arm group label:
Treatment Arm
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
130mg/m2, intravenous infusion,d1 of each cycle*8cycles
Arm group label:
Treatment Arm
Intervention type:
Procedure
Intervention name:
TME surgery
Description:
laparoscopic or robotic TME surgery for non-cCR patients
Arm group label:
Treatment Arm
Other name:
total mesorectal excision
Intervention type:
Procedure
Intervention name:
watch and wait
Description:
WW for cCR patients
Arm group label:
Treatment Arm
Other name:
WW
Summary:
phase II clinical trial to evaluate node-sparing short-course radiation combined with
total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.
Detailed description:
This is an open-label, prospective, single-center phase II clinical trial to evaluate
node-sparing short-course radiation (Radiation targeting the tumor bed without
irradiating surrounding tumor-draining lymph nodes) combined with total neoadjuvant CAPOX
and PD-1 Inhibitor (Sintilimab) for patients with MSS locally advanced of middle and low
rectal cancer. A total of 47 patients will be enrolled in this trial. The primary
endpoint is the complete response(CR) rate, which includes cCR and pCR. The organ
preservation rate, tumor regression grade, 3-year DFS, 3-year OS, and adverse effects
will also be analyzed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients who have a strong willingness to preserve the anus and are willing to
receive neoadjuvant therapy.
- Male or Female aged 18-75.
- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- No previous treatment(including anti-tumor therapy、immunotherapy or pelvic
radiation).
- 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;
- Informed consent form signed.
Exclusion Criteria:
- Patients with a previous history of malignant tumors besides rectal cancer.
- Patients with distant metastases before enrollment.
- Patients with positive internal or external iliac lymph nodes are assessed by MRI or
CT.
- Patients with obstruction, perforation, or bleeding that require emergency surgery.
- Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
- Allergic to any component of the therapy.
- Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, or
mucinous adenocarcinoma.
- Patients who received immunosuppressive or systemic hormone therapy for
immunosuppressive purposes within 1 month prior to the initiation of therapy.
- Patients who have received any other experimental drug (including immunotherapy) or
participated in another interventional clinical trial within 30 days before
screening.
- 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.
- Patients with congenital or acquired immune deficiency (such as HIV infection).
- Vulnerable groups, including mentally ill, cognitively impaired, critically ill
patients, minors, pregnant or lactating women, illiterate, etc.
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:
Zhejiang University Affiliated Jinhua Hospital
Address:
City:
Jinhua
Zip:
0579
Country:
China
Contact:
Last name:
Cheng Cai, master
Phone:
+8618395995912
Email:
ColoSurg_cc@zju.edu.cn
Investigator:
Last name:
Jinlin Du, master
Email:
Principal Investigator
Investigator:
Last name:
Cheng Cai, master
Email:
Sub-Investigator
Start date:
March 1, 2024
Completion date:
September 1, 2028
Lead sponsor:
Agency:
Jinhua Central Hospital
Agency class:
Other
Source:
Jinhua Central Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06204094
