Single-arm, Phase II Clinical Study Evaluating the Safety and Efficacy of Sintilimab Combined Wit… (NCT07750951) | Clinical Trial Compass
RecruitingPhase 2
Single-arm, Phase II Clinical Study Evaluating the Safety and Efficacy of Sintilimab Combined With IBI-310 and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
China34 participantsStarted 2026-05-29
Plain-language summary
Observation and evaluation of the safety and efficacy of PD-1 antibody combined with IBI310 and neoadjuvant chemotherapy in the treatment of locally advanced rectal cancer
Primary objectives:
Pathological complete response (pCR) rate;
Secondary objectives:
Treatment-related adverse events (CTCAE 5.0), clinical complete response (cCR) rate, major pathological response (MPR) rate, R0 resection rate, sphincter preservation rate, surgical complications, 3-year disease-free survival (DFS), and overall survival (OS);
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The absolute neutrophil count (ANC)≥1.5x109/L without granulocyte colony stimulating factor in the past 14 days;
. Platelets≥100×109/L without blood transfusion in recent 14 days;
. Hemoglobin \>9g/dl without blood transfusion or use of erythropoietin in recent 14 days;
. Total bilirubin ≤ 1.5×upper limit of normal (ULN);
. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5×ULN;
. Serum creatinine≤1.5×ULN and creatinine clearance (calculated by Cockcroft Gault formula)≥60ml/min;
. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT)≤1.5times ULN;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathological complete response (PCR) rate
Timeframe: Surgery (within 4-6 weeks of the last administration)
. Thyroid function was normal, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
Exclusion criteria
. Prior to the first administration, if the HBV viral load is less than 1000 copies/ml (200 IU/ml), subjects should receive anti HBV treatment throughout the entire study chemotherapy period to avoid viral reactivation;
. For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of viral reactivation is required;
. Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the detection limit);