A Phase III Trial of Anus-preservation in Low Rectal Adenocarcinoma Based on MMR/MSI Status
NCT ID: NCT05669092
Last Updated: 2022-12-30
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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RECRUITING
PHASE3
174 participants
INTERVENTIONAL
2022-11-01
2025-12-31
Brief Summary
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The rate of complete response (sustained cCR for ≥ 1 year), long-term prognosis and adverse effects will be analyzed.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARM A: dMMR/MSI-H patients
patients will receive 12 cycles of PD-1 antibody
Toripalimab
3mg/Kg iv d1q2w
ARM B: dMMR/MSI-H patients
patients will receive 5\*5Gy short-course radiotherapy, followed by 12 cycles of PD-1 antibody
Toripalimab
3mg/Kg iv d1q2w
SCRT
25Gy/5fx
ARM C: pMMR/MSS patients
patients will receive CRT followed by 6 cycles of XELIRI
CRT
IMRT 50Gy/25fx 625mg/m2 bid d1-5 qw Irinotecan:1、Full wild (GG+6/6): 80mg/m2/week for 5 times 2、Single site mutation (GG+6/7 or GA+6/6): 65mg/m2/week for 5 times 3、Double locus mutation (GG+7/7 or AA+6/6 or GA+6/7): 50mg/m2/week for the 1st, 2nd, 4th and 5th week for 4 times
XELIRI
Capecitabine: 1000mg/m2 bid d1-14 Irinotecan: 200mg/m2 ivgtt d1 q3w
ARM D: pMMR/MSS patients
patients will receive CRT followed by 12 cycles of FOLFRINOX
CRT
IMRT 50Gy/25fx 625mg/m2 bid d1-5 qw Irinotecan:1、Full wild (GG+6/6): 80mg/m2/week for 5 times 2、Single site mutation (GG+6/7 or GA+6/6): 65mg/m2/week for 5 times 3、Double locus mutation (GG+7/7 or AA+6/6 or GA+6/7): 50mg/m2/week for the 1st, 2nd, 4th and 5th week for 4 times
FOLFRINOX
Irinotecan: 150mg/m2 ivgtt d1 (double locus mutation downregulated to 120mg/m2) Oxaliplatin: 85mg/m2 ivgtt d1 5-FU: 2400mg/m2 ivgtt 46h q2w
Interventions
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Toripalimab
3mg/Kg iv d1q2w
CRT
IMRT 50Gy/25fx 625mg/m2 bid d1-5 qw Irinotecan:1、Full wild (GG+6/6): 80mg/m2/week for 5 times 2、Single site mutation (GG+6/7 or GA+6/6): 65mg/m2/week for 5 times 3、Double locus mutation (GG+7/7 or AA+6/6 or GA+6/7): 50mg/m2/week for the 1st, 2nd, 4th and 5th week for 4 times
SCRT
25Gy/5fx
XELIRI
Capecitabine: 1000mg/m2 bid d1-14 Irinotecan: 200mg/m2 ivgtt d1 q3w
FOLFRINOX
Irinotecan: 150mg/m2 ivgtt d1 (double locus mutation downregulated to 120mg/m2) Oxaliplatin: 85mg/m2 ivgtt d1 5-FU: 2400mg/m2 ivgtt 46h q2w
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. clinical stage T2-4 and/or N+，Not suitable for initial local excision to achieve radical treatment；
3. the distance from anal verge less than ≤ 5cm，or surgical evaluation concludes that direct surgical anal preservation is not possible without distance metastases；
4. age 18-70 years old, female and male；
5. Strong desire for anal preservation and ability to be closely monitored for at least 2 years after chemoradiotherapywith good compliance；
6. without distant metastases；
7. ECOG Performance status 0-1；
8. Detection of UGT1A1\*6 and \*28 gene status (for pMMR patients)；
9. Sufficient bone marrow reserve and physical capacity to receive consolidation chemotherapy after chemoradiotherapy (for pMMR patients)；
10. with good compliance；
11. signed the inform consen.
Exclusion Criteria
2. Persons with a history of uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders whose clinical severity, as judged by the investigator, may prevent the signing of informed consent or affect the patient's compliance with oral medications；
3. Difficult to achieve complete remission at the available level of evidence, such as: tumor largest diameter \>10 cm; largest diameter of lateral lymph nodes \>2 cm; baseline CEA \>= 100; biopsy pathology with an indolent cell carcinoma component; tumor of circumferential narrowing type on anal finger examination, with inclusion decided by the judgment of the evaluation team if necessary；
4. Clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months；
5. persons requiring immunosuppressive therapy for organ transplantation；
6. Persons with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases；
7. Subjects with baseline routine blood and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g/L; absolute neutrophil count (ANC) ≥ 1.5×109/L; platelets ≥ 100×109/L; ALT, AST ≤ 2.5 times the upper limit of normal; ALP ≤ 2.5 times the upper limit of normal; serum total bilirubin \< 1.5 times the upper limit of normal; serum creatinine \< 1 times the upper limit of normal limit; serum albumin ≥30g/L；
8. Known to have dihydropyrimidine dehydrogenase (DPD) deficiency；
9. allergic to any investigational drug component.
18 Years
70 Years
ALL
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Ji Zhu
professor
Locations
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Zhengjiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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JI ZHU
Role: primary
References
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Huang CY, Bai MH, Shen JW, Sun QQ, Feng YR, Chen QP, Mao W, Ju HX, Zhu J. Anus preservation in low rectal adenocarcinoma based on MMR/MSI status (APRAM): a study protocol for a randomised, controlled, open-label, multicentre phase III trial. BMC Cancer. 2024 Jan 10;24(1):57. doi: 10.1186/s12885-024-11829-2.
Other Identifiers
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CARTOnG 2201
Identifier Type: -
Identifier Source: org_study_id