Status:
UNKNOWN
Tislelizumab Plus Anlotinib for Immunotherapy Resistant Gastrointestinal Cancer
Lead Sponsor:
Peking University
Conditions:
Gastric Cancer
Colo-rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Immunotherapy acquired resistance was observed in clinical practice. The investigators intended to add anlotinib to PD-1 inhibitors, hoping reverse the resistance.
Detailed Description
Anti-angiogenesis seems have positive effects on tumor immune microenvironment. the combination of PD-1/PD-L1 inhibitors and TKIs exhibited favorable efficacy on gastrointestinal malignancies. Here th...
Eligibility Criteria
Inclusion
- ECOG scored 0 or 1, ≥18 years old, expected OS≥3 months;
- Histology confirmed unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma or colorectal cancer;
- ≥1 evaluable lesion based on RECIST 1.1;
- Patients received PD-1/PD-L1 in the last treatment line, and should meet following conditions:
- i) there was no severe immune-related adverse events, ii) the duration between tumor progression and screening should be 3-12 weeks, iii) the best evaluation results should be PR or CR when receiving PD-1/PD-L1 treatment but progression was confirmed in the latest evaluation, iv) patients were diagnosed with special pathology subtypes, that are sensitive to immunotherapy, such as dMMR, MSI-H tumors, or gastric cancer with PD-L1 CPS≥10, PFS≥6 months in the last treatment line;
- laboratory test should meet following standard: i) HB≥90g/l, neutrophils≥1.5\*10\^9/L, plt≥100\*10\^9, ii) ALT and AST\<2.5xULN (5ULN for liver metastatic patients), TBIL≤2×ULN, Cr≤1.5×ULN, and Ccr\>50μmol/L iii) APTT, INR and PT≤1.5×ULN iv) LVEF≥50%
- for female participants, Hcg should be negative and both male and female participants should have contraception measures
- participants should be informed consent, and voluntary.
Exclusion
- received anlotinib or other TKIs previously;
- allergic to other monoclonal antibody before the treatment;
- diagnosed with other malignancy in last five years (cured skin basal carcinoma, prostate cancer or cervical caner in situ were excluded)
- concurrent with other active autoimmune disease;
- any condition that require immune suppressor, such as cortisol (\>10mg/d prednisone equally), CTX;
- conditions affect oral absorption (eg: dysphagia, intestinal obstruction; chronic diarrhea);
- uncontrolled pleural effusion, hydropericardium and seroperitoneum;
- brain metastasis;
- received other anti-tumor treatment in past 3 weeks, eg: surgery, radiotherapy, target therapy, immunotherapy, and traditional Chinese therapy (target therapy less than 5 half-life period, 5-Fu less than 14 days were excluded);
- concurrent with uncontrolled other diseases, i) hypertension (\>150/90mmHg) ii) unstable angina pectoris, ≥ level 2 heart failure, arrhythmia within last 6 months; iii) clinical meaningful liver disease, eg: active HBV/HCV hepatitis; iv) HIV positive; v) uncontrolled diabetes; vi) urine protein ≥++ or 24h urine protein \>1g;
- injected vaccine in past 4 weeks, or administrated with antibiotics;
- investigator assumed improper conditions, such as mental disease, family or society factors.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04777162
Start Date
March 1 2021
End Date
May 1 2023
Last Update
March 4 2021
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142