Clinical trial NCT06333769: Modified SCRT Followed by Tislelizumab Plus CAPOX for Locally Advanced Rectal Cancer
Official title: A Phase II Multicenter Clinical Trial of Modified Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Mid-low Rectal Cancer
Keywords: short-course radiotherapy
CAPOX
PD-1 monoclonal antibody
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Complete response (CR) rate
timeFrame: From enrollment to 3 month and during follow-up
Secondary outcomes:
measure: Organ preservation rate
timeFrame: 1 year.
measure: Quality of life
timeFrame: Before each treatment, before surgery and during follow-up.
measure: 3y-DFS
timeFrame: From enrollment to 36 month
measure: 3-year OS
timeFrame: From enrollment to 36 month
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Longyan
country: China
facility: The Second Hospital of Longyan
state: Fujian
city: Quanzhou
country: China
facility: Jinjiang Municipal Hospital
state: Fujian
Study officials:
References: