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)

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Beijing Cancer Hospital
COMPLETED
Beijing
Beijing Chaoyang Hospital, Capital Medical University
COMPLETED
Beijing
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Hospital
COMPLETED
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Xuanwu Hospital, Capital Medical University
COMPLETED
Beijing
Contact Information
Primary
Zhongtao Zhang, M.D.
zhangzht@ccmu.edu.cn
+8613801060364
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 186
Treatments
Experimental: CRT+concurrent PD-1 inhibition (Experiment Arm 1)
Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 8 of radiation therapy. TME surgery is scheduled in 8\~12 weeks after completion of radiation.
Experimental: CRT+sequential PD-1 inhibition (Experiment Arm 2)
Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 8\~12 weeks after completion of radiation.
Active_comparator: CRT without PD-1 inhibition (Control Arm)
Long-course chemoradiation plus PD-1 inhibition with no PD-1 inhibition. TME surgery is scheduled in 6\~12 weeks after completion of radiation.
Related Therapeutic Areas
Sponsors
Collaborators: BeiGene, Peking Union Medical College Hospital, Xuanwu Hospital, Beijing, Peking University First Hospital, Peking University Cancer Hospital & Institute, Beijing Chao Yang Hospital, Beijing Hospital, Peking University People's Hospital
Leads: Beijing Friendship Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials