NCT04510818

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 head-and-neck-cancer

Timeline
Completed

Started Aug 2020

Typical duration for phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 10, 2020

Last Update Submit

August 12, 2020

Conditions

Head and Neck CancerEsophageal Squamous Cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of adverse events as assessed by CTCAE v5.0

    48 months

Secondary Outcomes (5)

  • Progression free survival

    48 months

  • Overall survival

    48 months

  • Objective response rate

    48 months

  • Disease control rate

    48 months

  • Duration of response

    48 months

Study Arms (1)

Experimental

EXPERIMENTAL

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

Drug: Capecitabine, Camrelizumab

Interventions

Capecitabine, CamrelizumabDRUG

This is a single-arm study with all patients receiving these two drugs.

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male/female patients aged≥18 years.
  • Histologically confirmed Head and neck cancer or Esophageal squamous cancer, without uncontrolled pleural effusion or ascites.
  • Patients with advanced or metastatic disease who have disease progression after first standard regimen, with measurable or unmeasurable lesions.
  • MSS or pMMR.
  • ECOG performance status 0 to 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Ruijin Hospital

Shanghai, 200025, China

RECRUITING

Related Publications (1)

  • Zhou C, Yin Y, Shangguan C, Wu Q, Cai Q, Xi W, Guo L, Jiang J, Shi M, Wu J, Ji J, Zhang X, Sun Y, Rensen SSM, Damink SWMO, Zhu Z, Zeng R, Zhang J. Lipid metabolism associated with efficacy of metronomic capecitabine and camrelizumab in gastrointestinal cancer: an exploratory clinical trial. BMC Med. 2025 Oct 21;23(1):572. doi: 10.1186/s12916-025-04377-4.

    PMID: 41121239DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Capecitabinecamrelizumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Jun Zhang, MD & Ph. D

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Liu

CONTACT

+86-18001753364liujing23@vip.163.com

Chengfang Shangguan

CONTACT

+86-13816860375sgcf11674@rjh.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Department of Oncology

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 12, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2024

Last Updated

August 14, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)