Clinical study of unresectable or metastatic carcinoma of pancreas, biliary tract and periampulle with Camrelizumab combined with low-dose apatinib

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000040080

Enrollment

Unknown

Registered

2020-11-20

Start date

2020-12-01

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carcinoma of pancreas, biliary tract and periampulle

Interventions

The experimental group:Camrelizumab + Apatinib

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. Patients with locally advanced or metastatic pancreatic, biliary and periampulvular cancers that are unresectable; 3. Patients who have not received immunotherapy or anti-angiogenesis therapy before but have received adjuvant chemotherapy or first-line chemotherapy can be included; 4. At least one measurable lesion (CT scan length of tumor lesion >=10 mm, CT scan short diameter of lymph node lesion >=15 mm, scanning thickness not greater than 5 mm); 5. The function of the major organs is good, the relevant examination indicators within the first 14 days of random meet the following requirements: (1) Blood routine examination: 1) Hemoglobin >=100 g/L (no blood transfusion within 14 days); 2) Neutrophil count >1.5 x 10^9/L; 3) Platelet count >=100x10^9/L; (2) Biochemical examination: (1) Total bilirubin =60 ml/min (Cockcroft-Gault formula); 6. Subjects voluntarily participate in this study and sign informed consent, with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1) Having other malignant tumors in the past or at the same time; 2) Patients who have previously used PD-1/PD-L1 antibody; 3) Have a history of bleeding, and have any bleeding event with a severe grade of 3 or above in CTCAE4.0 within 4 weeks before screening; 4) urine routine indicated urinary protein >=++ and confirmed 24-hour urinary protein quantitative >1.0 g; 5) Hypertensive patients with poor control; 6) Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other cases requiring corticosteroid use; 7) Have a history of chronic autoimmune diseases, such as systemic lupus erythematosus, ulcerative enteritis, crohn's disease and other inflammatory bowel diseases; 8) Other conditions that the researcher deems inappropriate for inclusion in the group.

Design outcomes

Primary

Measure	Time frame
Progression-free survival;	—

Countries

China

Contacts

Public ContactShujian Chang

Affiliated Hospital of Jiangnan University

changsj88265@sina.com+86 18861530277

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026