What is Tislelizumab studying for locally advanced rectal cancer?

Tislelizumab is being studied in combination with chemoradiation to evaluate its effects on treatment outcomes for mid-low locally advanced rectal cancer. Researchers want to see if adding this PD-1 inhibitor improves tumor response and survival rates compared to chemoradiation alone. The study is sponsored by Beijing Friendship Hospital and involves multiple centers.

Who may be eligible for this locally advanced rectal cancer clinical trial?

Adults aged 18 to 75 years diagnosed with stage II or III rectal adenocarcinoma without metastasis may be eligible. Both men and women can participate if they have not received prior anti-cancer treatments and have no immune system disorders. Please review eligibility criteria for more details.

Is there any cost to participate in this locally advanced rectal cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years - 75Years

All Genders

ID05245474

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)

Led by Beijing Friendship Hospital · Updated on 2024-01-10

186

Participants Needed

Research Sites

287 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of adding Tislelizumab, a PD-1 inhibitor, to long-course chemoradiation treatment before surgery for patients with mid-low locally advanced rectal cancer. This phase II, multi-center, open-label, randomized trial compares two experimental groups receiving chemoradiation combined with Tislelizumab at different timings and a control group receiving chemoradiation alone. The study focuses on patients aged 18 to 75 years with stage II/III rectal adenocarcinoma without metastasis, aiming to improve treatment outcomes such as complete tumor response and survival rates. Participants will be randomly assigned to one of three groups: Experiment Arm 1 receives chemoradiation plus concurrent Tislelizumab starting on Day 8 of radiation; Experiment Arm 2 receives chemoradiation plus sequential Tislelizumab starting two weeks after radiation completion; Control Arm receives chemoradiation only. All groups undergo total mesorectal excision (TME) surgery after 6 to 12 weeks post-radiation. Tislelizumab is administered at 200 mg per dose, three times at three-week intervals for the experimental arms. During the study, participants will undergo various assessments including tumor response evaluation within 10 days after surgery, adverse event monitoring, and follow-up for disease-free and overall survival up to five years post-operation. Researchers will also assess sphincter preservation rates, surgical complications, immune-related side effects, and quality of life scores throughout the study period. Data will be analyzed to compare outcomes between groups and determine the potential benefits and risks of adding Tislelizumab to standard chemoradiation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Aged 18 to 75 years
ECOG performance status score of 0 to 2
Biopsy confirmed rectal adenocarcinoma with distal margin within 10 cm of the anal verge
No distant metastasis, staged II or III by MRI, excluding T4b
Rectal cancer lesion diameter 10 mm or larger based on baseline CT or MRI
Willing and able to follow the study protocol
Consent to use of blood and tissue samples for research
No prior anti-tumor treatments such as radiation, chemotherapy, immunotherapy, or biological therapy
No immune system disorders such as lupus, rheumatoid arthritis, vasculitis, scleroderma, autoimmune anemia, thyroid disorders, HIV infection, and related diseases
No significant dysfunction of major organs including heart, lung, liver, kidney
No jaundice or gastrointestinal obstruction
No active infection
Acceptable blood and biochemical test results including neutrophils ≥1.5×10⁹/L, hemoglobin ≥80 g/L, platelets ≥100×10⁹/L, serum creatinine ≤1.5 times upper limit normal, total bilirubin ≤1.5 times upper limit normal, ALT and AST ≤2.5 times upper limit normal
No social or mental disorders
For women of childbearing potential, negative pregnancy test and effective contraception from enrollment until 60 days after last study drug dose

You will not qualify if you...

Multiple cancers or other malignant tumors besides rectal cancer
Received any anti-cancer treatment including surgery or drugs in the past 5 years
History of recent major surgery
Conditions affecting absorption of capecitabine (e.g., swallowing difficulties, nausea, vomiting, chronic diarrhea)
Uncontrolled or severe other diseases
Allergy to any study ingredients
Estimated survival less than or equal to 5 years for any reason
Preparing for or previously received organ or bone marrow transplant
Received immunosuppressive or systemic hormone therapy for immunosuppression within 1 month prior to enrollment
History of central nervous system disorders that may affect informed consent or medication compliance
Other conditions that may affect study results or lead to early treatment termination (e.g., alcoholism, drug abuse)
Pregnant or breastfeeding women, or women planning to conceive during treatment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 5 to 6 weeks of chemoradiation, with PD-1 blockade administered 3 times at 3-week intervals in experimental arms

Participants receive long-course chemoradiation with or without PD-1 blockade (Tislelizumab) depending on their assigned arm. Experiment Arm 1 receives Tislelizumab starting on Day 8 of radiation, Experiment Arm 2 receives Tislelizumab starting 2 weeks after radiation, and Control Arm receives chemoradiation only.

Multiple visits during chemoradiation and Tislelizumab administration per treatment schedule

Surgery

Duration - Single surgical event with immediate recovery

Participants undergo total mesorectal excision (TME) surgery scheduled 6 to 12 weeks after completion of radiation therapy.

1 surgical visit (in-person)

Follow-up

Duration - Up to 5 years post-surgery

Participants are monitored for safety, adverse events, and long-term outcomes including survival and quality of life up to 5 years after surgery.

Regular follow-up visits scheduled over 5 years

Trial Site Locations

Total: 8 locations

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100050

Actively Recruiting

Beijing Cancer Hospital