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Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510818
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Jun Zhang, Ruijin Hospital

Study Description
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Brief Summary:

This is a single center phase 1 trail to observe safety and efficacy of metronomic Capecitabine plus Camrelizumab as second-line regimen to treat head and neck cancer or esophageal squamous 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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Esophageal Squamous Cancer Drug: Capecitabine, Camrelizumab Phase 1

Detailed Description:
Head and neck cancer / Esophageal squamous cancer patients who have disease progression after first standard regimen 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Trail to Observe Safety and Efficacy of Metronomic Capecitabine Plus Camrelizumab as Second-line Regimen to Treat Head and Neck Cancer or Esophageal Squamous Cancer Patients
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of adverse events as assessed by CTCAE v5.0 [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 48 months ]
  2. Overall survival [ Time Frame: 48 months ]
  3. Objective response rate [ Time Frame: 48 months ]
  4. Disease control rate [ Time Frame: 48 months ]
  5. Duration of response [ Time Frame: 48 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male/female patients aged≥18 years.
  2. Histologically confirmed Head and neck cancer or Esophageal squamous cancer, without uncontrolled pleural effusion or ascites.
  3. Patients with advanced or metastatic disease who have disease progression after first standard regimen, with measurable or unmeasurable lesions.
  4. MSS or pMMR.
  5. ECOG performance status 0 to 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510818


Contacts
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Contact: Jing Liu +86-18001753364 liujing23@vip.163.com
Contact: Chengfang Shangguan +86-13816860375 sgcf11674@rjh.com.cn

Locations
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China
Department of Oncology, Ruijin Hospital Recruiting
Shanghai, China, 200025
Contact: Jun Zhang, MD & Ph. D    +86-13818332497    junzhang10977@sjtu.edu.cn   
Principal Investigator: Jun Zhang, MD & Ph. D         
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Jun Zhang, MD & Ph. D Ruijin Hospital
More Information
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Responsible Party: Jun Zhang, Chair of Department of Oncology, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04510818    
Other Study ID Numbers: McCrest-2
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Capecitabine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents