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New treatment option for Rectal Cancer
Official title Short-Course Radiotherapy Followed by Immunotherapy Combined With Chemotherapy for Microsatellite Stable Locally Advanced Rectal Cancer: A Prospective, Randomized, Controlled Phase II Clinical Trial
ClinicalTrials.gov ID: NCT07594925
What this study is testing
What is Sintilimab?
Sintilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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
- Microsatellite stable (MSS) locally advanced rectal cancer (LARC) remains a major therapeutic challenge despite advances in multimodal treatment. Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer-related death.
- 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
- Age 18-75 years, regardless of gender;
- Stage II/III disease (cT3-T4N0 or cT2-4N+) without distant metastasis on magnetic resonance imaging (MRI) or endoscopic ultrasound (EUS), according...
- The lower boundary of the lesion is ≤ 10 cm from the anal verge, confirmed by colonoscopy or digital rectal examination;
- Pathologically confirmed or re-reviewed rectal adenocarcinoma;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
You likely can't join if
- Previous treatment with anti-PD-1/L1, anti-CTLA-4 immunotherapeutic drugs, or other experimental immunotherapeutic agents;
- Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis...
- Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia;
- Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal...
- History of other malignant tumors, excluding curable non-melanoma skin cancer and carcinoma in situ of the cervix;
- Patients with active infection, heart failure, myocardial infarction within 6 months, unstable angina pectoris, or unstable arrhythmia;
See the full eligibility criteria
- Age 18-75 years, regardless of gender;
- Stage II/III disease (cT3-T4N0 or cT2-4N+) without distant metastasis on magnetic resonance imaging (MRI) or endoscopic ultrasound (EUS), according to the 8th edition of the AJCC Cancer Staging Manual (2018);
- The lower boundary of the lesion is ≤ 10 cm from the anal verge, confirmed by colonoscopy or digital rectal examination;
- Pathologically confirmed or re-reviewed rectal adenocarcinoma;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Meet the following laboratory diagnostic indicators: Hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.5×10⁹/L;
- Neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 100×10⁹/L;
- Creatinine ≤ 1.0×upper normal limit (UNL), blood urea nitrogen (BUN) ≤ 1.0×UNL;
- Alanine aminotransferase (ALT) ≤ 1.5×UNL;
- Aspartate aminotransferase (AST) ≤ 1.5×UNL;
- Alkaline phosphatase (ALP) ≤ 1.5×UNL;
- Total bilirubin (TBIL) ≤ 1.5×UNL;
- Urinary protein (-); normal bleeding and coagulation time.
- No history of allergy to platinum-based drugs;
- For patients with primary rectal cancer, no surgery (except palliative colostomy), chemotherapy, or other anti-tumor treatments have been performed from diagnosis to enrollment;
- No previous radiation therapy to the intended radiation field;
- Signed informed consent form.
- Previous treatment with anti-PD-1/L1, anti-CTLA-4 immunotherapeutic drugs, or other experimental immunotherapeutic agents;
- Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such...
- Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia;
- Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation;
- History of other malignant tumors, excluding curable non-melanoma skin cancer and carcinoma in situ of the cervix;
- Patients with active infection, heart failure, myocardial infarction within 6 months, unstable angina pectoris, or unstable arrhythmia;
- Physical examination or clinical laboratory findings that the investigator believes may interfere with the results or increase the risk of treatment complications in patients, or other uncontrollable diseases;
- Lactating or pregnant women;
- Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or history of organ transplantation or allogeneic stem cell transplantation;
- Known active hepatitis B virus (HBV) infection (HBV-DNA ≥ 2000 U/mL), hepatitis C virus (HCV) infection, or active pulmonary tuberculosis infection;
- Patients who have received tumor vaccines or other vaccines within 4 weeks before the start of treatment; (Note: Seasonal influenza vaccines for injection are mostly inactivated vaccines and thus allowed, while...
- Patients receiving concurrent use of other immunomodulators, chemotherapeutic drugs, drugs in other clinical studies, or long-term cortisol therapy are not eligible for enrollment;
- Patients with mental illness, substance abuse, or social problems that affect compliance will not be enrolled after review by doctors;
- Patients with allergies or contraindications to the study drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, 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 Tianjin, 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.