To hear about similar clinical trials, please enter your email below
Trial Title:
Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study
NCT ID:
NCT06390982
Condition:
RECTAL NEOPLASMS
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Oxaliplatin
Tislelizumab
Conditions: Keywords:
tislelizumab
low rectal cancer
organ preservation
watch and wait
TNT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week.
Arm group label:
tislelizumab
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200 mg IV on Day 1 of each 21-day cycle.
Arm group label:
tislelizumab
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in
CAPOX regimen
Arm group label:
tislelizumab
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen
Arm group label:
tislelizumab
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy.
Arm group label:
tislelizumab
Summary:
This is an open-label, multi-center, single-arm clinical study. All patients received
concurrent chemoradiation therapy (CRT) followed by 4 cycles of tislelizumab combined
with CAPOX, then underwent clinical response assessment. Patients who achieved CR (cCR+
pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for
another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not
achieved CR underwent total mesorectal excision (TME).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able to provide written informed consent, understand and comply with the
requirements and evaluation schedule
2. ≥18, ≤75 years old
3. Histologically confirmed rectal adenocarcinoma
4. immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR
/NGS confirmed MSI-L or MSS
5. The distance from the lower edge of the tumor to the anal verge is ≤5 cm through
colonoscopy, digital anal examination or MRI
6. clinical stage cT1-3N1M0 or cT2-3N0M0 (the 8th UICC/AJCC; T and N is evaluated by
MRI)
7. Resectable primary tumor assessed by the Investigator
8. Have not received any anti-tumor treatment for rectal cancer
9. ECOG PS ≤ 1
10. Adequate organ function
11. Female subjects with the ability to become pregnant must have a serum pregnancy test
with a negative result within 72 hours before the first dose, and be willing to use
highly effective contraceptive methods during the trial and 120 days after the last
dose. Male subjects whose partners are women of childbearing potential should be
surgically sterilized or agree to use a highly effective method of contraception
during the trial and for 120 days after the last dose.
Exclusion Criteria:
1. Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma,
mucinous adenocarcinoma and signet ring cell carcinoma
2. Have received any treatments for rectal cancer, or evidence of distant metastasis
3. Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive
lateral lymph nodes, T3d
4. Presence or in high risk of obstruction, perforation or bleeding;
5. Not suitable for long-course radiotherapy
6. Cannot tolerate surgery
7. ≥2 colorectal cancer lesions at the same time
8. Contraindications for MRI examination
9. Other malignant tumors in the past or at the same time
10. Have an active autoimmune disease requiring systemic therapy within the past 2 years
11. HIV infection
12. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA
> 500 IU/mL) or active HCV carriers with detectable HCV RNA;
13. Hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin or
to any component of the container
14. Other conditions judged by the researcher that do not meet the enrollment
requirements
Gender:
All
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Changzheng Hospital
Agency class:
Other
Collaborator:
Agency:
Huadong Hospital
Agency class:
Other
Collaborator:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Collaborator:
Agency:
First Hospital of China Medical University
Agency class:
Other
Collaborator:
Agency:
Liaoning Cancer Hospital & Institute
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06390982
