Status:
UNKNOWN
Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 1)
Lead Sponsor:
Ruijin Hospital
Conditions:
Advanced Cervical Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a single center phase 1 trail to observe safety and efficacy of metronomic capecitabine plus PD-L1 antibody camrelizumab as third-line regimen to treat HER2 negative advanced gastric cancer pa...
Detailed Description
HER2 negative advanced gastric cancer patients who have disease progression after two standard regimens will be treated by metronomic capecitabine plus camrelizumab. Metronomic capecitabine will be gi...
Eligibility Criteria
Inclusion
- Male/female patients aged≥18 years.
- Histologically confirmed gastric or gastric esophageal junction adenocarcinoma, without uncontrolled pleural effusion or ascites.
- Patients with advanced or metastatic disease who have disease progression after two standard regimens, with measurable or unmeasurable lesions.
- HER2 negative, MSS or pMMR.
- ECOG performance status 0 or 2, expected lifetime≥3 months.
- Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
- HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA\<500IU/ml (or 2500 copies/ml).
- Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
- Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.
Exclusion
- Pregnancy or children bearing potential.
- brain or meningeal metastasis.
- With second primary malignant diseases.
- With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone).
- With uncontrollable complications
- Inadequate organ function
- Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
- known hypersensitivity reaction to any of the study drugs or components.
- Other unsuitable conditions determined by investigators.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04508686
Start Date
August 1 2020
End Date
August 1 2024
Last Update
January 29 2021
Active Locations (1)
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1
Department of Oncology, Ruijin Hospital
Shanghai, China, 200025