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
Qualifiers
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
Treatments tested in this trial
- PD-1 inhibitor
- Capecitabine
- Long-course radiation therapy
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov