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

NCT ID: NCT04932187

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2025-07-01

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Capecitabine, Camrelizumab

Intervention Type: DRUG

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

Interventions

Capecitabine, Camrelizumab

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhang

Chair of Department of Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Zhang, MD & Ph. D

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Department of Oncology, Ruijin Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Min Shi, MD & Ph. D

Role: CONTACT

sm11998@rjh.com.cn

+86-21-64370045

Facility Contacts

Jun Zhang, MD & Ph. D

Role: primary

junzhang10977@sjtu.edu.cn

+86-13818332497

References

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.

Reference Type: DERIVED

PMID: 41121239 (View on PubMed)

Other Identifiers

McCrest-3

Identifier Type: -

Identifier Source: org_study_id