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Trial Title:
TIME in Immunotherapy Combined With nCRT for Rectal Cancer
NCT ID:
NCT05507112
Condition:
Locally Advanced Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Tislelizumab
Immune Checkpoint Inhibitors
Conditions: Keywords:
Rectal Cancer
Immunotherapy
neoadjuvant therapy
Tumor Immune Microenvironment
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PD-1 inhibitor
Description:
Tislelizumab (3 cycles): 200mg i.v. q3w on day 1 of each cycle, and starting from the
second week after the start of radiotherapy
Arm group label:
Neoadjuvant chemoradiotherapy plus PD-1 inhibitor
Other name:
Tislelizumab
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine 1650mg/m2/d orally twice-daily, 5 days a week for a total of 5 weeks.
Arm group label:
Neoadjuvant chemoradiotherapy
Arm group label:
Neoadjuvant chemoradiotherapy plus PD-1 inhibitor
Other name:
Xeloda
Intervention type:
Radiation
Intervention name:
Long-course radiation therapy
Description:
45-50 Gy/day, 5 days a week for a total of 5 weeks.
Arm group label:
Neoadjuvant chemoradiotherapy
Arm group label:
Neoadjuvant chemoradiotherapy plus PD-1 inhibitor
Summary:
This is an open-label, prospective phase II clinical trial to evaluate the therapeutic
and prognostic implications of tumor immune microenvironment in the neoadjuvant
immunotherapy combined with chemoradiotherapy for patients with rectal cancer. A total of
100 patients will be enrolled in this trial. The primary end point is the rate of
pathological complete response (pCR). The long-term prognosis and adverse effects will
also be evaluated and analyzed.
Detailed description:
Objectives:
1. To clarify the efficacy and safety of combined therapy for locally advanced rectal
cancer (LARC) patients and verify the efficacy and safety of neoadjuvant
immunotherapy for dMMR/MSI-H LARC patients.
2. To clarify the effect of nCRT on TIME for rectal cancer, and the further effect of
adding Immunotherapy.
3. To verify the feasibility of predicting the efficacy of combined therapy by the
infiltration level of CD8+ PD1+ TILs in tumor tissue before treatment in pMMR/MSS
LARC patients and explore the comprehensive prediction index of the efficacy of
combined therapy for LARC patients.
4. To clarify the potential mechanism of immune response or immune escape to
neoadjuvant immunotherapy for LARC patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years and ≤75 years on the day of signing informed consent.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
3. Histologically proven rectal adenocarcinoma.
4. <12 cm from anal verge.
5. Clinical stage of T3/T4 or N positive and M0
6. No previous chemotherapy, radiotherapy, immunotherapy or surgical treatment
7. No immune system disease (e. g. systemic lupus erythematosus (SLE), rheumatoid
arthritis (RA), systemic vasculitis, scleroderma, mixed connective tissue disease,
dermatomyositis (DM), hyperthyroidism, hypothyroidism, ulcerative colitis (UC),
autoimmune hemolytic anemia (AIHA) or human immunodeficiency virus (HIV) infection.
8. Adequate hepatic and renal function to chemoradiotherapy, immunotherapy and surgery.
9. Willing and able to provide written informed consent.
Exclusion Criteria:
1. Allergic to any component of chemotherapy or immunotherapy;
2. Patients with multiple primary colorectal cancer;
3. Other malignant tumors within 5 years, except for adequately treated cervical
carcinoma in situ or cutaneous basal cell carcinoma, or basically controlled
localized prostate cancer or surgically excised ductal carcinoma in situ of breast;
4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding,
or other conditions requiring emergency surgical resection;
5. Prior or planed organ/bone marrow transplant
6. Patients who receive systemic steroid therapy or immunosuppressive agents within 30
days before enrollment in the study;
7. Pregnant or lactating women
8. Patients with a history of severe mental illness or being unable to comply with the
research protocols.
9. Patients who have contraindications to chemoradiotherapy, immunotherapy or surgery.
10. Patients who have any other conditions that investigator judges unsuitable to
participate.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
September 20, 2022
Completion date:
December 1, 2029
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05507112
