Short-Course Radiotherapy Followed by Immunotherapy Plus Chemotherapy for Locally Advanced Rectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase II randomized trial, patients with stage II/III MSS locally advanced rectal cancer receive a short-course radiotherapy regimen followed by a combination of immunotherapy (Sintilimab) and standard chemotherapy. The goal is to see if this sequence can improve tumor response and downstaging before surgery compared with the current standard approach. The study uses careful eligibility criteria to select adults with good performance status and adequate organ function, and it is conducted at a major cancer center in Tianjin, China. Outcomes include safety, pathological response, and surgical feasibility after neoadjuvant treatment. This design aims to refine preoperative therapy for rectal cancer and potentially reduce recurrence risk.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute & Hospital, Key Laboratory of Cancer Prevention and Therapy, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Maobin Meng
• Email: mmeng@tmu.edu.cn
• Phone: +86 15202231270

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.