Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer
NCT ID: NCT06751394
Last Updated: 2024-12-27
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
44 participants
INTERVENTIONAL
2025-01-01
2028-12-31
Brief Summary
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The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints were R0 resection rate, 3-year progression-free survival, overall survival, pathological tumor regression grade, operation characteristics and incidence of major surgical complications.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group A
The patients will receive 2 cycles of XELOX or XELIRI and PD-1 antibody, followed by long course radiotherapy (45-50Gy/25f or 30Gy/25f), concurrent with Capecitabine and 1-2 cycles of PD-1 antibody, then receive 2-3 cycles of XELOX or XELIRI and PD-1 antibody. Curative surgery is scheduled after neoadjuvant treatment.
PD-1 antibody (Toripalimab)
PD-1 antibody: (Toripalimab): 240mg q3w
Capecitabine
Capecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy
Oxaliplatin
130 mg/m² q3w
Irinotecan
200 mg/m² q3w
Radiation
45-50Gy/25Fx or 30Gy/15Fx
surgery
The type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons.
Interventions
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PD-1 antibody (Toripalimab)
PD-1 antibody: (Toripalimab): 240mg q3w
Capecitabine
Capecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy
Oxaliplatin
130 mg/m² q3w
Irinotecan
200 mg/m² q3w
Radiation
45-50Gy/25Fx or 30Gy/15Fx
surgery
The type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons.
Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status 0-1.
3. Pathological confirmed or MRI/ enhanced CT confirmed pelvic recurrence.
4. No distant metastasis lesions outside the pelvic.
5. No prior radiotherapy within 6 months.
6. Participants with pelvic recurrence who have not previously been treated with first-line chemotherapy.
7. Life expectancy at least 24 weeks.
8. Adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating factors.
9. Non pregnancy or lactation.
10. Fully informed and willing to provide written informed consent for the trial.
Exclusion Criteria
2. TBIL \> 1.5 ULN.
3. AST or ALT \> 2.5 ULN, or ALT and / or AST \> 5 ULN in patients with liver metastasis.
4. Cr \> 1.5 ULN.
5. Serious electrolyte abnormalities.
6. Active coronary artery disease, severe/unstable angina, or newly diagnosed angina or myocardial infarction within 12 months.
7. Arterial thrombosis or deep vein thrombosis within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis.
8. Congestive cardiac failure ≥ NYHA grade 2.
9. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B defined as HBV-DNA ≥ 500 IU/ml; hepatitis C defined as HCV-RNA higher than lower limit of detection) or hepatitis B and hepatitis C virus co-infection.
10. Active inflammatory bowel disease or other colorectal diseases that lead to chronic diarrhea.
11. Suspected autoimmune disease.
12. Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia).
13. Suspected allergic to any drugs used in the trial.
14. History of any immune checkpoint inhibitor therapy.
15. Clinically detectable second primary malignancy, or history of other malignancies within 5 years.
16. Pregnant or lactating women or women who may be pregnant have a positive pregnancy test before the first medication; Or the female participants themselves and their partners who were unwilling to implement strict contraception during the study period.
17. The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems.
18. Serious mental abnormalities.
18 Years
75 Years
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Xiaojian Wu
hospital director
Locations
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Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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2024ZSLYEC-684
Identifier Type: -
Identifier Source: org_study_id