Colorectal Cancer
Conditions
Keywords
SHR-3821, Colorectal cancer
Brief summary
To evaluate the safety and efficacy of SHR-3821 combined with fruquintinib in the advanced colorectal cancer after failure of standard therapy
Detailed description
This is a single-center, open-label, exploratory phase II clinical trial designed to investigate the efficacy and safety of SHR-3821 in combination with fruquintinib for the treatment of metastatic colorectal cancer.
Interventions
DRUGSHR-3821 and fruquintinib
SHR-3821, administered by intravenous infusion Fruquintinib, administered orally
Sponsors
Meng Qiu
Jiangsu Hengrui Pharmaceutical Co., Ltd.
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. Histologically or cytologically confirmed unresectable recurrent or metastatic colorectal cancer. 2. Aged 18-75 years, male or female. 3. Failure of ≥2 lines of prior standard systemic therapy, which should have included oxaliplatin, irinotecan, and fluoropyrimidine-based chemotherapy. Subjects who failed first-line therapy are eligible if the first-line regimen contained all three chemotherapeutic agents, or if they exhibited intolerance or lack of response to oxaliplatin during adjuvant therapy. Subjects with dMMR/MSI-H tumors must also have failed anti-PD-1/PD-L1 antibody therapy. 4. Life expectancy ≥3 months. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1. 6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). 7. Adequate organ and bone marrow function within 7 days prior to the first dose, as defined below: 1. Hematology (without transfusion or growth factor support within 14 days): hemoglobin ≥90 g/L; platelet count ≥100×10\^9/L; white blood cell count ≥3.5×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L. 2. Liver function: total bilirubin ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase and alanine aminotransferase ≤2.5 × ULN (≤5 × ULN if liver metastases are present). 3. Renal function: serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula). 4. Coagulation: international normalized ratio ≤1.5 × ULN (or between 2.0 and 3.0 if on stable warfarin therapy); activated partial thromboplastin time and prothrombin time ≤1.5 × ULN. 8. Male patients and female patients of childbearing potential must use highly effective contraception during the study and for 12 months after the last dose. Female patients must be non-lactating and have a negative serum pregnancy test within 7 days before the first dose. 9. Voluntary participation, signed informed consent, good compliance, and willingness to cooperate with follow-up.
Exclusion criteria
1. Presence of concurrent active malignancies other than the primary tumor (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and gastrointestinal tumors confirmed cured by endoscopic mucosal resection). History of prior malignancy is allowed if the disease has been cured for ≥2 years. 2. Patients with untreated or active central nervous system (CNS) metastases or leptomeningeal metastasis. Patients are eligible if they have received local therapy, have stable neurological symptoms for at least 2 weeks prior to the first dose, and do not require corticosteroids or require ≤10 mg/day of prednisone (or equivalent). 3. Presence of severe complications at the primary site (e.g., perforation, obstruction, uncontrollable massive hemorrhage). 4. Uncontrolled or moderate-to-large pleural effusion or pericardial effusion. Clinically symptomatic moderate or severe ascites (patients with small ascites detected only by imaging without clinical symptoms are eligible). 5. Toxicities and/or complications from prior interventions have not recovered to ≤ Grade 1 per NCI CTCAE or to levels specified in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment related adverse event [Safety and Tolerability] | From the initiation of the first dose to 90 days after the last dose | To identify the incidence of adverse events (AEs) and severe adverse events (SAEs) in clinical trial |
| Objective response rate (ORR) | From enrollment to the end of treatment at 6 weeks | To evaluate the efficacy of anti-tumor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | From enrollment to the end of treatment at 6 weeks | To evaluate the efficacy of anti-tumor |
| Disease control rate (DCR) | From enrollment to the end of treatment at 6 weeks | To evaluate the efficacy of anti-tumor |
| Progression-free survival (PFS) | From enrollment to the end of treatment at 12 weeks | To evaluate the efficacy of anti-tumor |
| Overall survival (OS) | From enrollment to the end of treatment at 12 moths | To evaluate the efficacy of anti-tumor |
Contacts
CONTACTYuwen Zhou
Outcome results
None listed