Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study
NCT ID: NCT06390982
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
46 participants
INTERVENTIONAL
2024-05-31
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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tislelizumab
CRT followed by 4 cycles of tislelizumab plus CAPOX and clinical response assessment:
participants with CR (cCR+ pCR confirmed by local resection of ncCR): another 4 cycles of tislelizumab plus CAPOX and 9 cycles of tislelizumab, then watch and wait.
participants with non-CR: underwent TME
Radiotherapy
45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week.
Tislelizumab
200 mg IV on Day 1 of each 21-day cycle.
Capecitabine
Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen
Oxaliplatin
130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen
Capecitabine
825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy.
Interventions
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Radiotherapy
45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week.
Tislelizumab
200 mg IV on Day 1 of each 21-day cycle.
Capecitabine
Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen
Oxaliplatin
130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen
Capecitabine
825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Shanghai Changzheng Hospital
OTHER
Huadong Hospital
OTHER
RenJi Hospital
OTHER
Hebei Medical University Fourth Hospital
OTHER
First Hospital of China Medical University
OTHER
Liaoning Cancer Hospital & Institute
OTHER
Fudan University
OTHER
Responsible Party
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Xu jianmin
Chief Physician
Central Contacts
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Other Identifiers
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BGB-A317-2011-IIT
Identifier Type: -
Identifier Source: org_study_id
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