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Clinical Trial Record

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Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 3)

2021-08-01

2023-07-01

2025-07-01

20

Study Overview

Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 3)

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.

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.

  • Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi)
  • DRUG: Capecitabine, Camrelizumab
  • McCrest-3

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2021-06-17  

N/A  

2021-09-16  

2021-06-17  

N/A  

2021-09-17  

2021-06-21  

N/A  

2021-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Experimental

Capecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w

DRUG: Capecitabine, Camrelizumab

  • This is a single-arm study with all patients receiving these two drugs.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Rate of adverse events as assessed by CTCAE v5.048 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Progression free survival48 months
Overall survival48 months
Objective response rate48 months
Disease control rate48 months
Duration of response48 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Min Shi, MD & Ph. D

Phone Number: +86-21-64370045

Email: sm11998@rjh.com.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Jun Zhang, MD & Ph. D, Ruijin Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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