Status:
COMPLETED
Short-course Radiotherapy Based TNT Combined With PD-1 Inhibitor for Locally Advanced Rectal Cancer
Lead Sponsor:
Fudan University
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
TORCH is a prospective, multicentre, randomized phase II trial. 130 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group...
Eligibility Criteria
Inclusion
- Pathological confrmed adenocarcinoma
- Clinical stage T3-4 and/or N+
- The distance from anal verge ≤12 cm
- Without distance metastases
- Age 18-70 years old, female and male
- KPS \> =70
- Baseline blood and biochemical indicators meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90 g/L, PLT≥100×10\^9/L, ALT/AST≤2.5 ULN, Cr≤1 ULN
- With good compliance and signed the consent form
Exclusion
- Pregnancy or breast-feeding women
- Known history of other malignancies within 5 years
- Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc
- Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy)
- Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction
- Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment
- Uncontrolled infection which needs systemic therapy
- Active autoimmune disease or immunodefciencies, known history of organ transplantation or systematic use of immunosuppressive agents
- Known history of human immunodefciency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection
- Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (i.e., HBsAg positive or HBV DNA positive, HCV RNA positive if anti-HCV antibody testing positive)
- Allergic to any component of the therapy
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04518280
Start Date
May 1 2021
End Date
January 1 2025
Last Update
January 17 2025
Active Locations (3)
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1
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China, 200032
2
Zhen Zhang
Shanghai, Shanghai Municipality, China, 200032
3
Shanghai East Hospital
Shanghai, China