Status:
UNKNOWN
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
It is a single-center, retrospective, controlled study to investigate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low...
Detailed Description
Study Purpose 1. To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer. 2. To explore the effect...
Eligibility Criteria
Inclusion
- Patients with rectal adenocarcinoma must satisfied all the following conditions:
- Stage II/III LARC (cT1-4aN0-2M0);
- Tumor distal location≤10 cm from anal verge (MRI diagnosed);
- Patients regardless of gender with aged≥18 years
- ECOG score of 0 or 1
- Physical and viscera function of patients can withstand major abdominal surgery
Exclusion
- Current or previous active malignancy other than rectal cancer；
- Patients underwent major surgery within 4 weeks prior to neoadjuvant therapy；
- Patients have any condition affects the absorption of capecitabine through gastrointestinal tract；
- Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
- Patients with severe concomitant diseases with estimated survival≤5 years；
- Patients with present or previous moderate or severe liver and kidney damage；
- Patients preparing for or previously received organ or bone marrow transplant；
- Patients who have received immunosuppressive or systemic hormone therapy within 1 month prior to the start of neoadjuvant therapy；
- Patients with congenital or acquired immune deficiency (such as HIV infection)；
- Pregnant or lactating women.
Key Trial Info
Start Date :
September 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06024356
Start Date
September 20 2023
End Date
March 30 2024
Last Update
September 6 2023
Active Locations (1)
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1
Beijing Friendship Hospital, Capital medical University
Beijing, Xicheng Dis, China, 100050