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New treatment option for Advanced Colorectal Cancer
Official title Standard Second-line Therapy With ONgericimab and TOripalimab in pMMR/MSS Colorectal Cancer: a Single-arm Phase II Trial
ClinicalTrials.gov ID: NCT07106034
What this study is testing
What is Ongericimab + Toripalimab + Bevacizumab + FOLFOX?
Ongericimab + Toripalimab + Bevacizumab + FOLFOX is an investigational medicine, being studied as a potential treatment for advanced colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people 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...
- 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.
You likely can't join if
- Presence of leptomeningeal metastasis; presence of active brain metastasis, defined as untreated and/or having clinical symptoms, or requiring...
- Presence of pleural effusion, peritoneal effusion, or pericardial effusion with clinical symptoms or requiring repeated management (such as puncture...
- History of immunodeficiency disorders, including positive detection of human immunodeficiency virus (HIV), or known allogeneic organ transplantation...
- History of severe cardiovascular diseases, including but not limited to: myocardial infarction within 6 months before the first study drug...
- Presence of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first...
- Severe infection within 28 days before the first study drug administration (CTCAE 5.0 ≥ grade 2), such as severe pneumonia requiring hospitalization...
See the full eligibility criteria
Who can join
- people 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...
- 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.
- Adequate organ function；
- Female or male people 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- The following situations do not allow screening:
- Screening period imaging shows that the tumor encircles important blood vessels or has obvious necrosis and cavity, and the researcher deems it may cause bleeding risk;
- Clinical signs or symptoms of intestinal obstruction and/or gastrointestinal obstruction within 6 months before the first drug administration, including incomplete obstruction related to the underlying disease;
- Presence of severe, unhealed, or ruptured wounds, active ulcers, or untreated fractures;
- Clinically significant hemoptysis (≥1/2 tea spoon) or tumor bleeding for any reason within 1 month before the first drug administration;
- Presence of poorly controlled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure \> 100 mmHg), or history of hypertensive emergency or hypertensive encephalopathy;
- people with other conditions judged by the investigator to be unsuitable for bevacizumab therapy.
- Previous antineoplastic treatment toxicity has not recovered to grade 1 specified in CTCAE 5.0 or the level specified in the enrollment/exclusion criteria. Except for the following situations: if the researcher judges...
- Previous occurrence of drug-related adverse events leading to permanent drug discontinuation during treatment with bevacizumab and similar drugs.
- Received the following drugs or treatments before the first drug administration:
- Received chemotherapy, immunotherapy, radiotherapy or other anti-tumor therapies within 14 days prior to the first dose, including oral fluoropyrimidines, small-molecule targeted agents, traditional Chinese medicines...
- Underwent major surgery within 28 days prior to the first dose, or received core needle biopsy or other minor surgery (excluding placement of vascular access devices) within 7 days before the initiation of study...
- people who used systemic corticosteroids (≥10 mg prednisone equivalent per day) or other immunosuppressants for systemic treatment within 2 weeks before the first drug administration; inhalation or local use of...
- Received any live vaccine or attenuated vaccine within 28 days before the first drug administration, or need to receive live vaccines during the study period.
- Used antiplatelet therapy or anticoagulant therapy for therapeutic purposes within 10 days before the first drug administration.
- Pregnant or lactating women.
- Presence of other severe physical or mental diseases or abnormal laboratory examinations, which may increase the risk of participating in the study, affect treatment compliance, or interfere with the study results, and...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.