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Trial Title:
A Phase II Multicenter Clinical Study of Improved Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer
NCT ID:
NCT06333769
Condition:
Mid-low Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Oxaliplatin
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Short-course Radiotherapy
Description:
Rectal lesions + metastatic lymph nodes, DT: GTV-P 30Gy/5Fx. Pelvic lymphatic drainage
area, DT: CTV-P 22.5Gy/5Fx.
Arm group label:
Short-course Radiotherapy Combined with CAPOX and Tislelizumab
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab：200mg，d1，q3w，2 cycles.
Arm group label:
Short-course Radiotherapy Combined with CAPOX and Tislelizumab
Intervention type:
Drug
Intervention name:
capecitabine
Description:
capecitabine：1000mg/m2， d1-14，2 cycles.
Arm group label:
Short-course Radiotherapy Combined with CAPOX and Tislelizumab
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
oxaliplatin：130mg/m2 d1，q3w, 2 cycles
Arm group label:
Short-course Radiotherapy Combined with CAPOX and Tislelizumab
Summary:
To explore the complete response (CR) rate of improved short-course radiotherapy combined
with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18-75 years, any gender.
- Pathologically confirmed rectal adenocarcinoma.
- Baseline MR stage T3-4/N+.
- Distance from anal verge ≤12cm.
- No distant metastasis.
- Karnofsky Performance Status ≥70.
- Adequate organ function, no contraindications to surgery, radiotherapy, or
immunotherapy.
- Microsatellite/mismatch repair status MSS/pMMR.
- No prior chemotherapy or any other anti-tumor treatment before inclusion.
- No prior immunotherapy.
- Ability to comply with the study protocol during the study period.
- Signed written informed consent.
Exclusion Criteria:
- Pregnant or lactating women.
- Pathological diagnosis of signet ring cell carcinoma.
- History of other malignancies within the past 5 years, except cured skin cancer and
cervical carcinoma in situ.
- Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric
disorders that, in the opinion of the investigator, may interfere with signing the
informed consent form or affect patient compliance with oral medication.
- Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary
artery disease, New York Heart Association (NYHA) Class II or greater congestive
heart failure, or significant arrhythmias requiring drug intervention (see Appendix
12), or history of myocardial infarction within the past 12 months.
- Organ transplant recipients requiring immunosuppressive therapy and long-term
steroid users.
- Patients with autoimmune diseases.
- Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
- Subjects with baseline hematological and biochemical parameters not meeting the
following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10^9/L;
platelets ≥100×10^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times
the upper limit of normal; serum total bilirubin <1.5 times the upper limit of
normal; serum creatinine <1 times the upper limit of normal; serum albumin ≥30g/L.
- Known deficiency of dihydropyrimidine dehydrogenase (DPD).
- Allergy to any investigational drug components.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350500
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang C kang
Phone:
13509333116
Email:
chuck330@163.com
Start date:
July 12, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06333769
