Neoplasms

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Colorectal Neoplasms

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Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

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All Drugs and Chemicals

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Liver Extracts

Celecoxib

Regorafenib:in dose ramping stage,the initial dose is 80mg per dose, taken orally once a day. After 3 weeks of treatment, the medication is stopped for 1 week (i.e. from day 1 to day 21 and not from day 22 to day 28), with a treatment cycle of 4 weeks.The optimal recommended dose of regofinib (80mg, 120mg, or 160mg) obtained from the phase Ib dose ramping was included in the phase II study dose extension queue.

Toripalimab:240mg, intravenous drip, administered every three weeks. celecoxib:200mg each time, taken orally twice a day.

combination of Toripalimab,regorafenib and celecoxib

Rego+Tori+Cele

Yanhong Deng, docter

Yanghong Deng, PhD

Yanhong Deng, PhD

Research has found that patients with microsatellite instability (dMMR/MSI-H) type colorectal cancer can achieve long-term survival through immune checkpoint inhibitors (ICIs) treatment, but currently accounting for about 95% of MSS type mCRC, the benefits from immune checkpoint inhibitors are very limited. REGONIVO is a Phase Ib study to explore the efficacy and safety of regorafenib in combination with nivolumab in the treatment of gastric cancer and colorectal cancer with MSS. The study enrolled 50 patients with advanced disease, including 25 cases of gastric cancer, 25 cases of colorectal cancer, except for one case of colorectal cancer with MSI-H, and others were MSS type. The results of the study showed that patients with colorectal cancer had an objective response rate (ORR) of 36%.The ORR of liver matestasis vs. lung matestasis is 8.7% vs. 50%.

In this study, pMMR /MSS type patients with refractory advanced colorectal cancer without liver metastasis were selected as the subjects. Regorafenib, Toripalimab and Celecoxib were used to evaluate the maximum tolerable dose, objective response rate (ORR), total survival time (OS), progression free survival time (PFS), disease control rate (DCR), response duration (DoR) and safety of the subjects.

At present, the microsatellite stabilized (MSS) type of advanced refractory metastatic colorectal cancer (mCRC) has a poor median overall survival time of only about 7 months, and there is a significant unmet clinical demand for the efficacy of posterior treatment. Research has found that patients with microsatellite instability (dMMR/MSI-H) type colorectal cancer can achieve long-term survival through immune checkpoint inhibitors (ICIs) treatment, but currently accounting for about 95% of MSS type mCRC, the benefits from immune checkpoint inhibitors are very limited. REGONIVO is a Phase Ib study to explore the efficacy and safety of regorafenib in combination with nivolumab in the treatment of gastric cancer and colorectal cancer with MSS. The study enrolled 50 patients with advanced disease, including 25 cases of gastric cancer, 25 cases of colorectal cancer, except for one case of colorectal cancer with MSI-H, and others were MSS type. The results of the study showed that patients with colorectal cancer had an objective response rate (ORR) of 36%.The ORR of liver matestasis vs. lung matestasis is 8.7% vs. 50%.A phase Ib /Ⅱ clinical study REGOTORI enrolled 39 subjects, with a total ORR of 15.2%, and the ORR of non-liver metastasis subjects compared with liver metastasis subjects was 30% and 8.7% respectively. Based on the prospective small sample clinical trial results of other regifenib combined with PD-1 monoclonal antibody drugs, the overall ORR is between 0% and 33.3%, the ORR for non-liver metastases is between 20% and 50%, and the ORR for liver metastases is between 0% and 15%.

In this study, pMMR /MSS type patients with refractory advanced colorectal cancer without liver metastasis were selected as the subjects. Regorafenib, Toripalimab and Celecoxib were used to evaluate the maximum tolerable dose, objective response rate (ORR), total survival time (OS), progression free survival time (PFS), disease control rate (DCR), response duration (DoR) and safety of the subjects.

Toripalimab,Celecoxib and Regorafenib in the Treatment of Refractory Advanced Colorectal Cancer

Combination of Regorafenib，Toripalimab and Celecoxib in Mismatch Repair (MMR) Proficient Refractory Advanced Colorectal Cancer Without Liver Metastasis：a Single Arm Phase II REGOTORICOX Study.

Sun Yat-sen University

professor;chief physician

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Toripalimab,Celecoxib and Regorafenib in the Treatment of Refractory Advanced Colorectal Cancer	NCT05933980	Colorectal Canc... Liver Metastase... MSS	Rego+Tori+Cele	18 Years - 100 Years	Sun Yat-sen University
Toripalimab,Celecoxib and Regorafenib in the Treatment of Refractory Advanced Colorectal Cancer	NCT05933980	Colorectal Canc... Liver Metastase... MSS	Rego+Tori+Cele	18 Years - 100 Years	Sun Yat-sen University
Toripalimab,Celecoxib and Regorafenib in the Treatment of Refractory Advanced Colorectal Cancer	NCT05933980	Colorectal Canc... Liver Metastase... MSS	Rego+Tori+Cele	18 Years - 100 Years	Sun Yat-sen University

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