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New treatment option for Locally Advanced Rectal Cancer
Official title Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT05245474
What this study is testing
What is Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)?
Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor) is an investigational medicine, being studied as a potential treatment for locally advanced rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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)
You likely can't join if
- 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...
- with uncontrolled, severe, concomitant diseases of any sort
- allergic to any of the ingredients under study
See the full eligibility criteria
- 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...
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.