Standard Second-line Therapy With ONgericimab and TOripalimab in pMMR/MSS Colorectal Cancer: a Single-arm Phase II Trial
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Osoby w wieku od 18 do 75 lat.
- •Rak jelita grubego lub odbytnicy z mutacją pMMR/MSS, która nie zareagowała na wcześniejsze leczenie.
- •Ogólny stan zdrowia pozwalający na aktywne życie lub lekkie ograniczenia w aktywności.
- •Przewidywany czas przeżycia co najmniej 12 tygodni.
- •Widoczne zmiany chorobowe widoczne w badaniach obrazowych.
- •Dobre wyniki badań krwi wskazujące na sprawność narządów.
- •Kobiety i mężczyźni w wieku rozrodczym muszą zgodzić się na stosowanie skutecznych metod antykoncepcji.
- •Zgoda na udział w badaniu i przestrzeganie jego zasad.
✗ Disqualifies
- •Obecność przerzutów do opon mózgowych.
- •Aktywne przerzuty do mózgu, które wymagają leczenia lub powodują objawy.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- July 7, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Shanghai Pudong Hospital
Shanghai, China
Trial contact
Xuhui Bao, M.D., Ph.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/8/2026.
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