Long-Course Concurrent Chemoradiotherapy With Adebrelimab and Apatinib as Neoadjuvant Therapy for… (NCT07687433) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Long-Course Concurrent Chemoradiotherapy With Adebrelimab and Apatinib as Neoadjuvant Therapy for Locally Advanced/Low-Lying Rectal Cancer Requiring Sphincter Preservation
China43 participantsStarted 2026-05-29
Plain-language summary
To observe and evaluate the efficacy and safety of neoadjuvant long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib Mesylate in the treatment of locally advanced rectal cancer and low-lying rectal cancer with sphincter-preservation demand.
Who can participate
Age range
18 Years – 75 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
. Age: 18 to 75 years, male or female;
. Histologically or cytologically confirmed rectal cancer with measurable tumor lesion(s) (spiral CT or MRI scan ≥10 mm, meeting RECIST 1.1 criteria);
. Clinical stage: rectal cancer cT3-4N0M0 or cT1-4N+M0, and low rectal cancer with a sphincter-preservation requirement (distance from the anal verge \<5 cm; stage T2N0M0);
. Expected survival \>3 months;
. ECOG PS score: 0-1;
. No peritoneal metastasis or other distant metastasis;
. No prior radiotherapy or immune checkpoint inhibitor therapy for rectal cancer;
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
Complete Response Rate (cCR+pCR)
Timeframe: cCR assessed after neoadjuvant therapy; pCR assessed within 2 weeks post-surgery; assessed up to 6 months.
. Adequate function of vital organs as required (without the use of any blood components or cell growth factors during screening):
Exclusion criteria
. Prior pelvic or abdominal radiotherapy;
. Tumor expected to be unresectable after neoadjuvant therapy;
. Pregnant or breastfeeding women, or women/ men of childbearing potential who refuse to use contraceptive measures;
. 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;
. Uncontrolled symptomatic brain metastases, or poorly controlled psychiatric disorders, or severe intellectual or cognitive impairment;
. 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);
. 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;