rectal cancer
Conditions
Interventions
treatment group:long-course chemoradiotherapy plus adebrelimab and apatinib mesylate
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years, male or female; 2. Histologically or cytologically confirmed rectal cancer with measurable tumor lesion(s) (spiral CT or MRI scan =10 mm, meeting RECIST 1.1 criteria); 3. Clinical stage: rectal cancer cT3-4N0M0 or cT1-4N+M0, and low rectal cancer with a sphincter-preservation requirement (distance from the anal verge 3 months; 5. ECOG PS score: 0–1; 6. No peritoneal metastasis or other distant metastasis; 7. No prior radiotherapy or immune checkpoint inhibitor therapy for rectal cancer; 8. Adequate function of vital organs as required (without the use of any blood components or cell growth factors during screening): Absolute neutrophil count >=1.5×10?/L; platelet count >=80×10?/L; hemoglobin >=8.5 g/dL; Thyroid-stimulating hormone (TSH) <=1×ULN (if abnormal, T3 and T4 levels should also be assessed; patients with normal T3 and T4 levels may be enrolled); Bilirubin <=1.5×ULN; ALT and AST <=2.5×ULN; Serum creatinine <=1.5×ULN; 9. Women of childbearing potential must have a negative pregnancy test (ß-HCG) before starting treatment. Women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception consistently during treatment and for 6 months after the last dose; 10. Subjects voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Prior pelvic or abdominal radiotherapy; 2. Tumor expected to be unresectable after neoadjuvant therapy; 3. Pregnant or breastfeeding women, or women/ men of childbearing potential who refuse to use contraceptive measures; 4. History of other malignancies within the past 5 years, except for adequately treated cervical carcinoma in situ or cutaneous squamous cell carcinoma, or well-controlled basal cell carcinoma of the skin; 5. Uncontrolled symptomatic brain metastases, or poorly controlled psychiatric disorders, or severe intellectual or cognitive impairment; 6. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function; 7. Active, known, or suspected autoimmune disease. Subjects with stable conditions not requiring systemic immunosuppressive therapy are eligible, e.g., type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia); 8. Congestive heart failure, uncontrolled arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack, severe hypertension refractory to medication, or other conditions rendering the patient unable to tolerate surgery; 9. Severe active infection requiring intravenous antibiotic therapy during the screening period; 10. Known allergy to the study drug or any of its excipients, or a history of severe allergic reaction to other monoclonal antibodies; 11. Clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment; 12. Hypertension that remains uncontrolled despite antihypertensive therapy prior to enrollment; 13. Patients with dysphagia; 14. Receipt of or planned receipt of live vaccines within 30 days prior to administration of adebrelimab; 15. Known history of HIV infection, or active hepatitis B or hepatitis C; 16. Inability to comply with the study protocol or to cooperate with follow-up; 17. Other conditions that the investigator considers inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate (including cCR and pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Disease-Free Survival (DFS);Sphincter preservation rate;Objective Response Rate (ORR);Tumor Regression Grade (TRG);Pathologic Complete Response (pCR) Rate; | — |
Countries
China
Contacts
Public ContactChunbo Zhao
Harbin Medical University Cancer Hospital
Outcome results
None listed