A Single-arm, Open, Single-center Clinical Study of Sovalutinib in Combination With Solutumab and Tegeo in Second and Second Line for Advanced Pancreatic Cancer
Overview
- Phase
- Phase 2
- Intervention
- Sovalteinib Solutumab Tegeo
- Conditions
- Progression-free Survival
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 30
- Primary Endpoint
- PFS
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is a single-arm, open, single-center clinical study to observe and evaluate the efficacy and safety of sovalteinib in combination with solutumab and tegeo in second-line and post-line treatment of patients with advanced pancreatic cancer.
A total of 30 patients were enrolled in this study, which was divided into 3 phases: screening phase, treatment phase and follow-up phase. During the treatment period, tumor status was evaluated by imaging methods every 6 weeks (±7 days) until disease progression (PD, RECIST 1.1) or death (during patient treatment) or intolerable toxicity, and tumor treatment and survival status after disease progression were recorded. Safety observations included AE, changes in laboratory test values, vital signs, and changes in ECG. In addition, 10 ml of blood was drawn for testing in our laboratory before each treatment and at the time of disease progression before the patients were enrolled, and the exploration of the efficacy-related biomarker BRCA1 was performed by blood samples.
Investigators
Luo Cong
Deputy Director
Zhejiang Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following conditions for enrollment:
- •subjects voluntarily enrolled in this study and signed an informed consent form, with good compliance and cooperation with follow-up;
- •patients with unresectable focally advanced or metastatic pancreatic cancer diagnosed by pathological histology or cytology
- •age between 18 and 75 years (both 18 and 75 years), male or female
- •ECOG score: 0-1; expected survival ≥ 12 weeks;
- •have progressed after receiving at least one prior systemic therapy for locally progressive or metastatic pancreatic cancer (including patients on first- or second-line regimens containing 5-FU)
- •have at least one measurable lesion (according to RECIST 1.1 criteria); ≥ 10 mm in diameter as accurately measured by magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement, and at least 20 mm in diameter as determined by conventional CT scan
- •no serious organic diseases of the heart, lungs, brain and other organs;
- •essentially normal function of major organs and bone marrow:
- •routine blood (no blood transfusion, no granulocyte colony-stimulating factor \[G-CSF\], no drug correction within 14 days prior to screening): leukocytes ≥ 4.0 x 109/L, neutrophils ≥ 1.5 x 109/L, platelets ≥ 80 x 109/L, hemoglobin ≥ 90 g/L;
Exclusion Criteria
- •participation in other antitumor drug clinical trials within 4 weeks prior to enrollment, including: interventional, chemotherapy, bioimmunotherapy, targeted therapy, etc;
- •previous treatment with a previous vascular endothelial growth factor (VEGFR) inhibitor or previous treatment with an immune checkpoint inhibitor, and previous treatment with tegeo;
- •other malignancies within the past 5 years, except for basal or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix
- •patients who have developed any brain metastases or are currently developing brain metastases
- •with liver metastases representing 50% or more of the total liver volume as determined by the investigator
- •have undergone any surgery (other than biopsy) or invasive treatment or operation within 4 weeks prior to enrollment and the surgical incision has not fully healed (except for intravenous placement, puncture drainage, internal/external drainage procedures for obstructive jaundice, etc.)
- •have received local antitumor therapy such as hepatic artery interventional embolization, cryoablation of liver metastases or radiofrequency ablation within 4 weeks prior to enrollment;
- •clinically significant electrolyte abnormalities in the judgment of the investigator;
- •the patient has current hypertension that is not controlled by medication, specified as: systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg
- •urine routine suggestive of urine protein ≥ 2+ and 24-hour urine protein amount \> 1.0 g
Arms & Interventions
Prospective Research
Soventinib in combination with solutumab and tegeo dosing regimen: * Soventinib: 200 mg orally, within 1 hour of breakfast, administered once daily as a continuous dose, d1-d21, every 3 weeks in treatment cycles * Slulizumab: 300 mg administered intravenously, d1, every 3 weeks for one treatment cycle. * Tegeo: 40-60 mg/dose administered twice daily, d1-d14, continuously (dosing based on body surface area (BSA): 40 mg/dose for BSA ≤ 1.25 m2; 50 mg/dose for 1.25 ≤ BSA \< 1.5 m2 and 60 mg/dose for BSA ≥ 1.5 m2), every 3 weeks for one treatment cycle. Dose adjustments, including suspension, dose reduction, or permanent discontinuation, were allowed as required by the protocol.
Intervention: Sovalteinib Solutumab Tegeo
Outcomes
Primary Outcomes
PFS
Time Frame: through disease progression, an average of 6 months
Time between the start of treatment and the onset of (any aspect of) progression of the tumor or death (from any cause)
Secondary Outcomes
- ORR(through disease progression, an average of 6 months)
- DCR(through disease progression, an average of 6 months)
- OS(through patients' death, an average of 12 months)