RecruitingPhase 2NCT05245474

Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer

Efficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)

Sponsor

Beijing Friendship Hospital

Enrollment

186 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Rectal Cancer

Summary

This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequential PD-1 inhibitor) with a control group (chemoradiation only).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria15

aged 18~75
ECOG score 0~2
biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge
no distant metastasis, staged II/III (T4b excluded) by MRI
maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MRI (i.e. a "measurable lesion" as per RECIST 1.1 criteria)
willing and able to comply with study protocol
consent to the use of blood and tissue specimens for study
no history of previous anti-tumor treatment (e.g. radiation, chemo, immuno, bio, herbal, etc.)
no disorders/diseases of immune system (e.g. systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, hyperthyroidism/hypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.)
no significant dysfunction of major viscera (e.g. heart, lung, liver, kidney, etc.)
no jaundice or gastrointestinal obstruction
no acute/ongoing infection
no significant irregularities in blood routine test and biochemical test results, particular requirements include: neutrophils≥1.5×109/L, HGB≥80g/L, platelet≥100×109/L, serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, ALT、AST≤2.5×ULN
no social or mental disorder
for women of child-bearing age, a negative result of serological pregnancy test is required, and effective contraception measures from inclusion till 60 days after the last dose of study drug is required

Exclusion Criteria12

multiple cancers, or with concomitant malignant tumors besides rectal cancer
having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years
history of recent major surgery
with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.)
with uncontrolled, severe, concomitant diseases of any sort
allergic to any of the ingredients under study
estimated survival ≤ 5 years due to any reason
preparing for or having previously received organ or bone marrow transplant
having received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to inclusion
for patients with history of disorder of central nervous system, investigator discretion is required as to whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance
with other conditions/issues that may affect the study results or cause the study treatment to be terminated halfway (e.g. alcoholism, drug abuse, etc.)
pregnant or lactating women, or women intending on conception during treatment period

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Interventions

COMBINATION_PRODUCTLong-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)

Tislelizumab is added to long-course chemoradiation (CRT) of LARC patients, with CRT+concurrent Tislelizumab for Arm 1, CRT+sequential Tislelizumab for Arm 2, and CRT only for Arm 3