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Advanced Colorectal CancerPhase 2ONTOPNCT07106034

Standard Second-line Therapy With ONgericimab and TOripalimab in pMMR/MSS Colorectal Cancer: a Single-arm Phase II Trial

A Phase 2 study testing Ongericimab + Toripalimab + Bevacizumab + FOLFOX and Ongericimab + Toripalimab + Bevacizumab + FOLFIRI in people with Advanced Colorectal Cancer, run by Shanghai Pudong Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
Ongericimab + Toripalimab + Bevacizumab + FOLFOX and Ongericimab + Toripalimab + Bevacizumab + FOLFIRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
31 Aug 2025to 31 Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Adequate organ function；
  • 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.

Who cannot join

  • 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).
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  • 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).
  • 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;
  • Subjects 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 that the related toxicity is well-controlled and does not affect the safety and compliance of the subject using the study drug, screening is allowed.
  • 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 with anti-tumor indications, and palliative radiotherapy;
  • 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 treatment;
  • Subjects 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 corticosteroids or preventive medication (such as for infusion reaction/hypersensitivity reaction) is allowed;
  • 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 are judged by the researcher as unsuitable for participating in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xuhui Bao, M.D., Ph.D. contact

862168035001

xuhui_bao@fudan.edu.cn

China1 site, 1 recruiting

  • Shanghai Pudong Hospital

    Shanghai, Shanghai Municipality, 201399

    Xuhui Bao, M.D., Ph.D., 862168035001, xuhui_bao@fudan.edu.cn

    Xuhui Bao, M.D., Ph.D.

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of Second-Line Standard Therapy Combined With Ongericimab and Toripalimab in Patients With MSS/pMMR Colorectal Cancer Following First-Line Treatment Failure

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.

Being tested
Ongericimab + Toripalimab + Bevacizumab + FOLFOX, Ongericimab + Toripalimab + Bevacizumab + FOLFIRI
Keywords
Toripalimab, Ongericimab, colorectal cancer, pMMR/MSS
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ongericimab + Toripalimab + Bevacizumab + FOLFOXDrug

    Ongericimab, Toripalimab, Bevacizumab, Oxaliplatin, Calcium folinate, 5-FU, Q2W

  • Ongericimab + Toripalimab + Bevacizumab + FOLFIRIDrug

    Ongericimab, Toripalimab, Bevacizumab, Irinotecan, Calcium folinate, 5-FU, Q2W

Study groups in NCT07106034
Study groupRoleWhat they receive
Second-line standard treatment combined with Ongericimab and toripalimab.ExperimentalIf first line treatment with irinotecan-containing regimen: Ongrezicimab + Toripalimab + Bevacizumab + FOLFOX, Q2W If first line treatment with oxaliplatin-containing regimen: Ongrezicimab + Toripalimab + Bevacizumab + FOLFIRI, Q2W In addition, the period of 21 days after the first administration is defined as the DLT observation period.
Receives: Drug: Ongericimab + Toripalimab + Bevacizumab + FOLFOX; Drug: Ongericimab + Toripalimab + Bevacizumab + FOLFIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate

    overall response rate

    Measured: Two years

Secondary outcomes (4)

  1. Disease control rates

    Disease control rates

    Measured: Two years

  2. Duration of Response

    Duration of Response

    Measured: Two years

  3. progression-free survival

    progression-free survival

    Measured: Two years

  4. overall survival

    overall survival

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study start31 Aug 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07106034
Sponsor's protocol ID
ONTOP
Acronym
ONTOP
Status last verified
Jul 2026
First submitted
30 Jul 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ongericimab + Toripalimab + Bevacizumab + FOLFOX and Ongericimab + Toripalimab + Bevacizumab + FOLFIRI in people with Advanced Colorectal Cancer, run by Shanghai Pudong Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xuhui Bao, M.D., Ph.D. (862168035001, xuhui_bao@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07106034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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