Advanced Cervical Cancer
Conditions
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 patients. This study is one of the cohorts of a multi-cohort trial called Combination of Metronomic capecitabine with Camrelizumab for treatment of refractory solid tumor (McCrest) trial.
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 given as fixed dose (500mg bid) orally. Camrelizumab will be given two-weekly (200mg once) intravenously. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.
Interventions
This is a single-arm study with all patients receiving these two drugs.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male/female patients aged≥18 years. 2. Histologically confirmed gastric or gastric esophageal junction adenocarcinoma, without uncontrolled pleural effusion or ascites. 3. Patients with advanced or metastatic disease who have disease progression after two standard regimens, with measurable or unmeasurable lesions. 4. HER2 negative, MSS or pMMR. 5. ECOG performance status 0 or 2, expected lifetime≥3 months. 6. 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. 7. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA\<500IU/ml (or 2500 copies/ml). 8. Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment. 9. 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 criteria
1. Pregnancy or children bearing potential. 2. brain or meningeal metastasis. 3. With second primary malignant diseases. 4. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone). 5. With uncontrollable complications 6. Inadequate organ function 7. Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction). 8. known hypersensitivity reaction to any of the study drugs or components. 9. Other unsuitable conditions determined by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: adverse events as assessed by CTCAE v5.0 | 48 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | 48 months |
| Overall survival | 48 months |
| Objective response rate | 48 months |
| Disease control rate | 48 months |
| Duration of response | 48 months |
Countries
China
Contacts
Primary ContactJing Liu
Backup ContactChenfei Zhou
Outcome results
None listed