CompletedPhase 2

Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors

China189 participantsStarted 2022-09-01

Plain-language summary

immunotherapy，gastric cancer，rectal cancer，biomark

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5\*10\^9/L, hemoglobin ≥90g/L (5.58 mmol/L), and platelets ≥100\*10\^9/L.
✓. The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥50 mL/minute (that is, if serum creatinine is \>1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).
✓. The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg/dL (25.65 μmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases).
✓. The patient must have adequate coagulation function as defined by international normalized ratio (INR) ≤1.5
✓. No hysterectomy or bilateral ovariectomy
✓. Natural menopause does not last for 24 months (amenorrhea after cancer treatment does not rule out fertility) (that is, menstruation occurs at any time in the previous 24 months).

✕. Skin diseases that do not require systematic treatment (e.g. vitiligo, hair loss, psoriasis or eczema)
✕. Hypothyroidism caused by autoimmune thyroiditis requires only a stable dose of hormone replacement therapy.
✕. Type I diabetes mellitus requiring only a stable dose of insulin replacement therapy
✕. Asthma has been completely relieved in childhood and no intervention is needed in adults.
✕. The researchers determined that the disease would not recur without external triggers.
✕. Within 6 months before the first administration, there were myocardial infarction, unstable angina pectoris, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (according to New York Heart Association functional grade 2 or above), symptomatic or poorly controlled arrhythmia, or any arterial thromboembolic event.
✕. There was a history of deep venous thrombosis, pulmonary embolism or other severe thromboembolism within 3 months before the first administration.
✕. There are major vascular diseases, such as aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis, which may be life-threatening or require surgery within 6 months.

Pathological complete response

Timeframe: 6 months

NCT IDNCT05515796

SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-25

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5\*10\^9/L, hemoglobin ≥90g/L (5.58 mmol/L), and platelets ≥100\*10\^9/L.
✓. The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥50 mL/minute (that is, if serum creatinine is \>1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).
✓. The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg/dL (25.65 μmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases).
✓. The patient must have adequate coagulation function as defined by international normalized ratio (INR) ≤1.5
✓. No hysterectomy or bilateral ovariectomy
✓. Natural menopause does not last for 24 months (amenorrhea after cancer treatment does not rule out fertility) (that is, menstruation occurs at any time in the previous 24 months).

✕. Skin diseases that do not require systematic treatment (e.g. vitiligo, hair loss, psoriasis or eczema)
✕. Hypothyroidism caused by autoimmune thyroiditis requires only a stable dose of hormone replacement therapy.
✕. Type I diabetes mellitus requiring only a stable dose of insulin replacement therapy
✕. Asthma has been completely relieved in childhood and no intervention is needed in adults.
✕. The researchers determined that the disease would not recur without external triggers.
✕. Within 6 months before the first administration, there were myocardial infarction, unstable angina pectoris, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (according to New York Heart Association functional grade 2 or above), symptomatic or poorly controlled arrhythmia, or any arterial thromboembolic event.
✕. There was a history of deep venous thrombosis, pulmonary embolism or other severe thromboembolism within 3 months before the first administration.
✕. There are major vascular diseases, such as aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis, which may be life-threatening or require surgery within 6 months.