TIME in Immunotherapy Combined With nCRT for Rectal Cancer
ConditionLocally Advanced Rectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years and ≤75 years on the day of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Histologically proven rectal adenocarcinoma.
<12 cm from anal verge.
Disqualifiers
Allergic to any component of chemotherapy or immunotherapy;
Patients with multiple primary colorectal cancer;
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;
Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgical resection;
Trial design
Design model
Parallel
Treatments tested in this trial
PD-1 inhibitor
DrugTislelizumab (3 cycles): 200mg i.v. q3w on day 1 of each cycle, and starting from the second week after the start of radiotherapy
Capecitabine
DrugCapecitabine 1650mg/m2/d orally twice-daily, 5 days a week for a total of 5 weeks.
Long-course radiation therapy
Radiation45-50 Gy/day, 5 days a week for a total of 5 weeks.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Neoadjuvant chemoradiotherapy plus PD-1 inhibitorExperimental treatment 3 interventions
Group B: Neoadjuvant chemoradiotherapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Pathological complete response (pCR) rates
Proportion of patients who achieve a pathological complete response following treatment
Time frame
1-2 weeks after surgerySecondary outcomes
1
Major pathological response (MPR) rates
The proportion of patients experiencing a major pathological response to neoadjuvant treatment.
Time frame
1-2 weeks after surgery2
Pathological tumor regression grade (TRG)
TRG is evaluated according to the AJCC system. TRG0-1 is defined as good response, TRG2 as moderate response, and TRG3 as poor response.
Time frame
1-2 weeks after surgery3
Rate of tumor down-staging
The proportion of patients experiencing tumor down-staging will be assessed by pathology.
Time frame
1-2 weeks after surgery4
Lymphocytes infiltration changes after treatment
The categories, number and distribution of lymphocytes infiltrated in tumor and tumor stroma are measured by Multiplex immunofluorescence assay.
Time frame
2 weeks before treatment and 1-2 weeks after surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: