- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04508686
Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 1)
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 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Shanghai, China, 200025
- Recruiting
- Department of Oncology, Ruijin Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental
Capecitabine 500mg bid.
po.
Camrelizumab 200mg ivgtt.
d1 q2w
|
This is a single-arm study with all patients receiving these two drugs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: adverse events as assessed by CTCAE v5.0
Time Frame: 48 months
|
48 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 48 months
|
48 months
|
Disease control rate
Time Frame: 48 months
|
48 months
|
Progression free survival
Time Frame: 48 months
|
48 months
|
Objective response rate
Time Frame: 48 months
|
48 months
|
Duration of response
Time Frame: 48 months
|
48 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- McCrest
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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