Description:
This is a single center phase 1 trial to observe safety and efficacy of metronomic
capecitabine plus PD-L1 antibody camrelizumab to treat hepatobiliary, pancreatic and other
gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression
after all standard regimens.
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.
Title
- Brief Title: Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 3)
- Official Title: Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor (McCrest) Trial: Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi) (Cohort 3)
Clinical Trial IDs
- ORG STUDY ID:
McCrest-3
- NCT ID:
NCT04932187
Conditions
- Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi)
Interventions
Drug | Synonyms | Arms |
---|
Capecitabine, Camrelizumab | | Experimental |
Purpose
This is a single center phase 1 trial to observe safety and efficacy of metronomic
capecitabine plus PD-L1 antibody camrelizumab to treat hepatobiliary, pancreatic and other
gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression
after all standard regimens.
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
Hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi)
patients who had disease progression after all 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.
Trial Arms
Name | Type | Description | Interventions |
---|
Experimental | Experimental | Capecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w | - Capecitabine, Camrelizumab
|
Eligibility Criteria
Inclusion Criteria:
1. Male/female patients aged≥18 years.
2. Histologically confirmed hepatobiliary, pancreatic and other gastrointestinal
carcinoma (non-stomach, non-esophagi), without uncontrolled pleural effusion or
ascites.
3. Patients with advanced or metastatic disease who have disease progression after all
standard regimens, with measurable or unmeasurable lesions.
4. 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Rate of adverse events as assessed by CTCAE v5.0 |
Time Frame: | 48 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Progression free survival |
Time Frame: | 48 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | 48 months |
Safety Issue: | |
Description: | |
Measure: | Objective response rate |
Time Frame: | 48 months |
Safety Issue: | |
Description: | |
Measure: | Disease control rate |
Time Frame: | 48 months |
Safety Issue: | |
Description: | |
Measure: | Duration of response |
Time Frame: | 48 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Ruijin Hospital |
Last Updated
June 21, 2021