Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by TME for LARC.

Last updated: February 7, 2022
Sponsor: Beijing Friendship Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04911517
BFH-NCRTPD
  • Ages > 18
  • All Genders

Study 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). Tislelizumab, an anti-PD1(programmed death 1) humanized IgG4 (Immunoglomin G4) monoclonal antibody, has been demonstrated with clinical activity and is approved for treating recurrent/refractory classical Hodgkin lymphoma and locally advanced/metastatic urothelial carcinoma in China.

The aim of This NCRT-PD-1-LARC trial is to evaluate the efficacy and safety of long course neoadjuvant chemoradiotherapy plus tislelizumab followed by total mesorecta excision for LARC. This NCRT-PD-1-LARC trial will be a prospective, multicenter and phase Ⅱ clinical trial designed to evaluate the safety and efficacy of LARC patients treated with long course neoadjuvant chemoradiotherapy plus tislelizumab followed by total mesorecta excision. It will consecutively enroll 50 stage II/III LARC patients (cT3N0M0 and cT1-3N1-2M0) with the tumor distal location ≤ 10cm from anal verge at 7 centers in China. The enrolled patients will receive long course radiotherapy (50 Gy/25 f, 2 Gy/f, 5 days/week) and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day8), followed by total mesorecta excision 6-12 week after the end of radiotherapy. The primary efficacy endpoint will be the pathological complete response (pCR) rate, which is defined as absence of viable tumor cells in the primary tumor and lymph nodes.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Patients have been fully aware of the content of this study and signed the informedconsent voluntarily;
  • Patients with rectal cancers must satisfied all the following conditions: Stage II/IIILARC (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 pregnancytest for child-bearing age women and they agree to use effective contraception for theduration of drug use and for 60 days after the last dose.

Exclusion

Exclusion criteria:

  • Patients have a present or previous active malignancy except the diagnosis of rectalcancer this time;
  • Patients underwent major surgery within 4 weeks prior to study treatment;
  • Patients have any condition affects the absorption of capecitabine throughgastrointestinal tract;
  • Patients have severe uncontrolled recurrent infections, or other severe uncontrolledconcomitant 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 presentlyor previously;
  • Patients have received other study medications or any immunotherapy currently or inthe past;
  • Patients preparing for or previously received organ or bone marrow transplant;
  • Patients who received immunosuppressive or systemic hormone therapy forimmunosuppressive 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 ormental disorder, the investigator will determine whether the clinical severityprevents the signing of informed consent or affects the patient's oral medicationcompliance;
  • Patients with other factors that may affect the study results or cause the study to beterminated midway, such as alcoholism, drug abuse, other serious diseases (includingmental illness) requiring combined treatment and severe laboratory examinationabnormalities.
  • Pregnant or lactating women

Study Design

Total Participants: 50
Study Start date:
June 01, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Beijing Friendship Hospital

    Beijing, Beijing 100050
    China

    Active - Recruiting

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