Mid-low Rectal Cancer
Conditions
Keywords
short-course radiotherapy, CAPOX, PD-1 monoclonal antibody
Brief summary
To explore the complete response (CR) rate of modified short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer
Detailed description
In the neoadjuvant treatment of rectal cancer, the new mode of short-course radiotherapy and chemotherapy combined with immunotherapy has shown good potential for application. Combining PD-1 antibody with short-course radiotherapy and chemotherapy to increase the tumour-killing and immune-mediated effects of the radiation dose may further improve tumour regression and increase the complete remission rate, providing a promising treatment option for patients with low-grade rectal cancer who are seeking a 'wait-and-see' strategy to preserve organ function.
Interventions
RADIATIONShort-course Radiotherapy
Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.
DRUGTislelizumab
Tislelizumab：200mg，d1，q3w，2 cycles.
DRUGCapecitabine
Capecitabine：1000mg/m2，d1-14，bid, q3w, 2 cycles.
DRUGOxaliplatin
Oxaliplatin：130mg/m2, d1, q3w, 2 cycles
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response (CR) rate | From enrollment to 3 month and during follow-up | Including pCR and CCR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Organ preservation rate | 1 year. | Sphincter-saving rate in enrolled patients |
| Quality of life | Before each treatment, before surgery and during follow-up. | EORTC Core Quality of Life questionnaire (QLQ-C30)，range from 0-100, with comprehensive assessment indicators, including positive and negative indicators. |
| 3y-DFS | From enrollment to 36 month | — |
| 3-year OS | From enrollment to 36 month | The percentage of patients enrolled who are still alive three years after their initial enrollment. |
Countries
China
Outcome results
None listed