Standard Second-line Therapy With ONgericimab and TOripalimab in pMMR/MSS Colorectal Cancer: a Si… (NCT07106034) | Clinical Trial Compass
RecruitingPhase 2
Standard Second-line Therapy With ONgericimab and TOripalimab in pMMR/MSS Colorectal Cancer: a Single-arm Phase II Trial
China32 participantsStarted 2025-08-31
Plain-language summary
The ONTOP study is a prospective, single-arm, open-label phase II clinical trial. A total of 32 patients with advanced MSS/pMMR colorectal cancer who have failed first-line treatment will receive second-line standard treatment combined with Ongericimab and toripalimab. Among them, patients who received irinotecan-containing treatment in the first line will be administered the regimen of Ongericimab + toripalimab + bevacizumab + FOLFOX. Patients who received oxaliplatin-containing treatment in the first line will be administered the regimen of Ongericimab + toripalimab + bevacizumab + FOLFIRI. Treatment will continue until disease progression, initiation of new anti-tumor treatment, active request of the subject, or determination by the investigator that study drug administration needs to be terminated. The primary study endpoint is the objective response rate (ORR), and the secondary study endpoints include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety, etc.
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
. Subjects aged 18-75 years (inclusive of 18 and 75 years) at the time of signing the informed consent, regardless of gender.
. Histologically confirmed MSS/pMMR colorectal or rectal cancer, who have progressed on first-line fluoropyrimidine - based combination therapy (including progression during maintenance therapy). If FOLFOXIRI was received in the first - line, screening is not allowed; if progression occurred during neoadjuvant/adjuvant therapy or within 6 months after the last dose, it is considered first-line treatment failure, and the patient is eligible for enrollment.
. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
. Predicted survival ≥ 12 weeks.
. At least 1 measurable lesion according to RECIST 1.1 evaluation criteria.
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.
. Female or male subjects with childbearing potential must agree to have no childbearing plans within 6 months after the end of the last dose during the study period and be willing to take highly effective contraceptive measures together with their partners. For female subjects with childbearing potential, the serum pregnancy test must be negative within 7 days before the first dose, and they must be non - lactating.
. Be able to provide a signed informed consent form, including complying with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.
Exclusion criteria
. Presence of leptomeningeal metastasis; presence of active brain metastasis, defined as untreated and/or having clinical symptoms, or requiring glucocorticoids or antiepileptic drugs to control related symptoms. For those who have received local treatments such as surgery or radiotherapy, if the screening - period imaging assessment shows no evidence of progression for at least four weeks and symptoms disappear (except for residual signs or symptoms related to brain metastasis), no glucocorticoid treatment is needed for at least 2 weeks, and the acute toxicities related to previous treatments have recovered, enrollment is allowed.
. Presence of pleural effusion, peritoneal effusion, or pericardial effusion with clinical symptoms or requiring repeated management (such as puncture or drainage).
. History of immunodeficiency disorders, including positive detection of human immunodeficiency virus (HIV), or known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
. History of severe cardiovascular diseases, including but not limited to: myocardial infarction within 6 months before the first study drug administration, severe/unstable angina pectoris, congestive heart failure (NYHA heart function class ≥2), severe supraventricular or ventricular arrhythmia, aortic aneurysm requiring surgical repair, any arterial thromboembolic event, grade 3 or above venous thromboembolic event, transient ischemic attack, cerebrovascular accident.
. Presence of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first drug administration.
. Severe infection within 28 days before the first study drug administration (CTCAE 5.0 ≥ grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active infection requiring intravenous anti-infection treatment or unexplained fever \> 38.5°C within 2 weeks before the first study drug administration (judged by the researcher; fever caused by the tumor in the subject can be enrolled).
. Presence of active tuberculosis, hepatitis B (hepatitis B surface antigen \[HBsAg\] positive and HBV DNA higher than the lower limit of detection of the research center), hepatitis C (HCV Ab positive and HCV RNA higher than the lower limit of detection of the research center).
. History of another primary malignant tumor, except for those who have received radical treatment before the first administration of the study intervention, have no known active disease (for more than 5 years), and have a low potential recurrence risk (such as skin basal cell carcinoma and cutaneous squamous cell carcinoma that have received curative treatment).