Preoperative Treatment with Radiotherapy and Anti-PD1 for Resectable Recurrent Rectal Cancer (TRACER)
Overview
- Phase
- Phase 2
- Intervention
- Radiation
- Conditions
- Recurrent Rectal Cancer
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Pathological complete response rate
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
The study is a prospective, single-center, single-arm, phase II clinical trial. Patients with pelvic recurrent rectal cancer aged from 18 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, will receive 45-50Gy/25Fx irradiation or 30Gy/15Fx reirradiation (history of pelvic radiation). PD-1 inhibitor (Toripalimab) was used throughout the course of induction chemotherapy (before radiation), concurrent chemoradiation and consolidation chemotherapy (after radiation); radical resection was followed by well-experienced surgeons .
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.
Investigators
Xiaojian Wu
hospital director
Sixth Affiliated Hospital, Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Patient is 18-75 years old at the time of signing the informed consent form.
- •ECOG performance status 0-
- •Pathological confirmed or MRI/ enhanced CT confirmed pelvic recurrence.
- •No distant metastasis lesions outside the pelvic.
- •No prior radiotherapy within 6 months.
- •Participants with pelvic recurrence who have not previously been treated with first-line chemotherapy.
- •Life expectancy at least 24 weeks.
- •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.
- •Non pregnancy or lactation.
- •Fully informed and willing to provide written informed consent for the trial.
Exclusion Criteria
- •Neutrophil \< 1.5×10\^9/L, PLT \< 75×10\^9/L.
- •TBIL \> 1.5 ULN.
- •AST or ALT \> 2.5 ULN, or ALT and / or AST \> 5 ULN in patients with liver metastasis.
- •Cr \> 1.5 ULN.
- •Serious electrolyte abnormalities.
- •Active coronary artery disease, severe/unstable angina, or newly diagnosed angina or myocardial infarction within 12 months.
- •Arterial thrombosis or deep vein thrombosis within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis.
- •Congestive cardiac failure ≥ NYHA grade
- •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.
- •Active inflammatory bowel disease or other colorectal diseases that lead to chronic diarrhea.
Arms & Interventions
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.
Intervention: Radiation
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.
Intervention: PD-1 antibody (Toripalimab)
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.
Intervention: Capecitabine
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.
Intervention: Oxaliplatin
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.
Intervention: Irinotecan
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.
Intervention: surgery
Outcomes
Primary Outcomes
Pathological complete response rate
Time Frame: up to 1 year
Defined as pathological evaluation of resected tumor tissue and regional lymph nodes, with no residual tumor cells, complete disappearance of all tumor lesions, and no appearance of new lesions.
Secondary Outcomes
- R0 resection rate(up to 1 year)
- 3-year Progression-Free Survival(up to 3 years)
- Overall Survival(up to 3 years)
- Pathological tumor regression grading(up to 1 year)
- Operation complications(up to 1 year)
- Incidence of major surgical complications(up to 3 months)