💬In plain words
What the trial is, and whether it could suit you
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. In China, rectal cancer accounts for nearly half of all colorectal cancers, with approximately 70% of patients presenting with locally advanced disease, which is associated with a high risk of recurrence and poor long-term survival.
Neoadjuvant chemoradiotherapy followed by total mesorectal excision (TME) has become the standard treatment for LARC based on landmark trials such as CAO/ARO/AIO-94, NSABP-R03, and MRC-CR07, which demonstrated improved local control and reduced recurrence. However, the optimal neoadjuvant strategy remains under active investigation.
Currently, long-course chemoradiotherapy and short-course radiothe
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Age 18-75 years, regardless of gender;
2. 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);
3. The lower boundary of the lesion is ≤ 10 cm from the anal verge, confirmed by colonoscopy or digital rectal examination;
4. Pathologically confirmed or re-reviewed rectal adenocarcinoma;
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
6. Meet the following laboratory diagnostic indicators:
Hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.5×10⁹/L;
7. Neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 100×10⁹/L;
8. Creatinine ≤ 1.0×upper normal limit (UNL), blood urea nitrogen (BUN) ≤ 1.0×UNL;
9. Alanine aminotransferase (ALT) ≤ 1.5×UNL;
10. Aspartate aminotransferase (AST) ≤ 1.5×UNL;
11. Alkaline phosphatase (ALP) ≤ 1.5×UNL;
12. Total bilirubin (TBIL) ≤ 1.5×UNL;
13. Urinary protein (-); normal bleeding and coagulation time.
14. No history of allergy to platinum-based drugs;
15. For patients with primary rectal cancer, no surgery (except palliative colostomy), chemotherapy, or other anti-tumor treatments have been performed from diagnosis to enrollment;
16. No previous radiation therapy to the intended radiation field;
17. Signed informed consent form.
Exclusion Criteria:
1. Previous treatment with anti-PD-1/L1, anti-CTLA-4 immunotherapeutic drugs, or other experimental immunotherapeutic agents;
2. Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.;
3. Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia;
4. 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;
5. History of other malignant tumors, excluding curable non-melanoma skin cancer and carcinoma in situ of the cervix;
6. Patients with active infection, heart failure, myocardial infarction within 6 months, unstable angina pectoris, or unstable arrhythmia;
7. 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;
8. Lactating or pregnant women;
9. Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or history of organ transplantation or allogeneic stem cell transplantation;
10. Known active hepatitis B virus (HBV) infection (HBV-DNA ≥ 2000 U/mL), hepatitis C virus (HCV) infection, or active pulmonary tuberculosis infection;
11. 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 intranasal preparations are usually live attenuated vaccines and thus not allowed);
12. Patients receiving concurrent use of other immunomodulators, chemotherapeutic drugs, drugs in other clinical studies, or long-term cortisol therapy are not eligible for enrollment;
13. Patients with mental illness, substance abuse, or social problems that affect compliance will not be enrolled after review by doctors;
14. Patients with allergies or contraindications to the study drugs.
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