Status:
UNKNOWN
Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by TME for LARC.
Lead Sponsor:
Beijing Friendship Hospital
Collaborating Sponsors:
Hangzhou New Horizon Health Technology Co., Ltd.
BeOne Medicines
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Long course radiotherapy plus neoadjuvant chemotherapy followed by resection total mesorecta excision has accepted widespread recognized in the treatment of locally advanced rectal cancer (LARC). Tisl...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients have been fully aware of the content of this study and signed the informed consent voluntarily;
- Patients with rectal cancers must satisfied all the following conditions: Stage II/III LARC (cT1-3N1-2M0)；Tumor distal location ≤10 cm from anal verge (MRI diagnosed);
- Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1;
- Physical and viscera function of patients can withstand major abdominal surgery;
- Patients are willing and able to follow the study protocol during the study;
- Patients give consent to the use of blood and pathological specimens for study;
- Within 28 days prior to enrolment, we must confirm a negative serological pregnancy test for child-bearing age women and they agree to use effective contraception for the duration of drug use and for 60 days after the last dose.
- Exclusion criteria:
- Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;
- Patients underwent major surgery within 4 weeks prior to study treatment;
- Patients have any condition affects the absorption of capecitabine through gastrointestinal tract;
- Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
- Patients who are allergic to any of the ingredients under study;
- Patients with severe concomitant diseases with estimated survival ≤ 5 years;
- Patients with present or previous moderate or severe liver and kidney damage presently or previously;
- Patients have received other study medications or any immunotherapy currently or in the past;
- Patients preparing for or previously received organ or bone marrow transplant;
- Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of study therapy;
- Patients with congenital or acquired immune deficiency (such as HIV infection);
- If patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator will determine whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance;
- Patients with other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment and severe laboratory examination abnormalities.
- Pregnant or lactating women
Exclusion
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04911517
Start Date
June 1 2021
End Date
December 1 2024
Last Update
February 23 2022
Active Locations (1)
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1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050