Using metronomic capecitabine and camrelizumab to treat advanced gastrointestinal cancers
Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor (McCrest) Trial: Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi) (Cohort 3)
This study is testing a new combination of two drugs, metronomic capecitabine and camrelizumab, to see if it can help people with advanced gastrointestinal cancers who haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | prednisone, camrelizumab |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04932187 on ClinicalTrials.gov |
What this trial studies
This phase 1 trial aims to evaluate the safety and efficacy of a combination treatment involving metronomic capecitabine and the PD-L1 antibody camrelizumab for patients with hepatobiliary, pancreatic, and other gastrointestinal carcinomas who have experienced disease progression after standard therapies. Patients will receive a fixed dose of capecitabine orally and camrelizumab intravenously every two weeks until disease progression, intolerable toxicity, or withdrawal of consent. The study is part of a larger multi-cohort trial focused on refractory solid tumors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced or metastatic hepatobiliary, pancreatic, or other gastrointestinal carcinomas who have progressed after standard treatments.
Not a fit: Patients with uncontrolled pleural effusion or ascites, or those who do not meet the eligibility criteria, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastrointestinal cancers who have limited treatment choices.
How similar studies have performed: While this approach is part of a multi-cohort trial, the specific combination of metronomic capecitabine and camrelizumab has not been widely tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Department of Oncology, Ruijin Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jun Zhang, MD & Ph. D — Ruijin Hospital
- Study coordinator: Min Shi, MD & Ph. D
- Email: sm11998@rjh.com.cn
- Phone: +86-21-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.