Advanced Colorectal Cancer
Conditions
Brief summary
A phase II study to assess the efficacy and safety of Surufatinib combined with Sintilimab as a second-line treatment in patients with advanced MSS-Type CRC.
Interventions
DRUGSurufatinib
Surufatinib(250mg ,qd,po)+Sintilimab(200mg,q3w,iv),21 days for a cycle.The curative effect was evaluated every 8 weeks.
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. For inclusion in study, patient must provide a written informed consent. 2. Male or female, age18-75 years. 3. Pathologically confirmed unresectable locally advanced or advanced MSS-Type metastatic colorectal adenocarcinoma . 4. The patient had previously failed standard first-line systemic chemotherapy,Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1. 6. Life expectancy \> 12 weeks. 7. Have measurable disease based on RECIST 1.1.
Exclusion criteria
1. Any therapy with anti-PD-1, or anti-PD-L1/l2 antibodies or anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody (or any other antibody acting on T cell costimulatory or checkpoint pathway) or fruquintinib treatment in previous. 2. Prior receipt of Surufatinib. 3. History of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc. (except patients with hypothyroidism that can be controlled only by hormone replacement therapy and patients with type I diabetes who only need insulin replacement therapy). 4. History of gastrointestinal perforation and/or fistula, ileus, inflammatory bowel disease, or extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months prior to first dosing. 5. Any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | up to 12 months | CR + PR rate according to the RECIST version 1.1 guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | up to 12 months | To assess the efficacy of Surufatinib Combined With Chemotherapy as second-line therapy to Advanced CRC, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). |
| Overall survival time | up to 36 months | Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines. |
| Assess the anti-tumor activity:DCR | up to 12 months | Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines. |
Countries
China
Contacts
Primary ContactZengqing Guo
Outcome results
None listed