Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PD-1 antibody (Toripalimab), Capecitabine, Oxaliplatin, Irinotecan.
- Who it may be relevant to
- Registry conditions: Recurrent Rectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Preoperative Treatment with Radiotherapy and Anti-PD1 for Resectable Recurrent Rectal Cancer (TRACER)
Overview
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.
Interventions
- Drug PD-1 antibody (Toripalimab)
PD-1 antibody: (Toripalimab): 240mg q3w - Drug Capecitabine
Capecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy - Drug Oxaliplatin
130 mg/m² q3w - Drug Irinotecan
200 mg/m² q3w - Radiation Radiation
45-50Gy/25Fx or 30Gy/15Fx - Procedure 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.
Primary outcome measures
- Pathological complete response rate [Time frame: up to 1 year]
Secondary outcome measures (6)
- R0 resection rate [Time frame: up to 1 year]
- 3-year Progression-Free Survival [Time frame: up to 3 years]
- Overall Survival [Time frame: up to 3 years]
- Pathological tumor regression grading [Time frame: up to 1 year]
- Operation complications [Time frame: up to 1 year]
- Incidence of major surgical complications [Time frame: up to 3 months]
Eligibility criteria
Inclusion criteria
- Patient is 18-75 years old at the time of signing the informed consent form.
- ECOG performance status 0-1.
- 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 2.
- 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.
- Suspected autoimmune disease.
- Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia).
- Suspected allergic to any drugs used in the trial.
- History of any immune checkpoint inhibitor therapy.
- Clinically detectable second primary malignancy, or history of other malignancies within 5 years.
- 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.
- 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.
- Serious mental abnormalities.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06751394 · 2024ZSLYEC-684