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

NCT04932187 | Unknown Phase 1

• 1 other identifier: McCrest-3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi)

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, Camrelizumab DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female patients aged≥18 years.
• Histologically confirmed hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi), without uncontrolled pleural effusion or ascites.
• Patients with advanced or metastatic disease who have disease progression after all standard regimens, with measurable or unmeasurable lesions.
• 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.

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.

Sponsors & Collaborators

• Ruijin Hospital: lead

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: 41121239 DERIVED

MeSH Terms

Interventions

Capecitabine; camrelizumab

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jun Zhang, MD & Ph. D

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Shi, MD & Ph. D

CONTACT

+86-21-64370045; sm11998@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: June 17, 2021
• First Posted: June 21, 2021
• Study Start: August 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2025
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)