The effect of PD-1 antibody and low-dose Apatinib on the treatment of inoperable or metastatic carcinoma of pancreas, biliary-tract or periampullary (phase II study)

The effect of PD-1 antibody and anti-VEGF on the treatment of inoperable or metastatic carcinoma of pancreas, biliary-tract or periampullary

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000029187

Enrollment

Unknown

Registered

2020-01-17

Start date

2020-01-06

Completion date

Unknown

Last updated

2020-01-20

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

Conditions

pancreas, biliary-tract or periampullary cancer

Interventions

Case series:PD-1 antibody (SHR-1210) 200 mg ,every 2 weeks

+ Apatinib 250 mg, once daily

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years old; 2. Patients with local advanced or metastatic carcinoma of pancreat, biliary tract ,or periampullary , confirmed by pathology; 3. Patients who have not received immunotherapy or antiangiogenic therapy before. Patients who have ever received adjuvant chemotherapy or first-line chemotherapy can be enrolled. 4. At least one measurable focus (tumor focus CT scan length >=10 mm, lymph node focus CT scan short Diameter >=15 mm, layer thickness not more than 5 mm); 5. The main organs function is well, and the indexes within 14 days before randomization meet the following requirements: Blood routine examination: Hemoglobin >=100 g/L; Neutrophil count > 1.5x10^9/L; platelet count >=100x10^9/L; Biochemical examination: Total bilirubin =60 ml / min (Cockcroft Gault formula); 6. The subjects voluntarily joined the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients who were suffering from other malignant tumors in the past or at the same time; 2) Patients who have used PD-1 / PD-L1 antibody before; 3) There was a history of haemorrhagic disease, and any bleeding event with a severe grade 3 or more occurred within 4 weeks before screening; 4) Routine urine test indicated that urine protein >=+ + and confirmed that 24-hour urine protein quantity was more than 1.0 G; 5) Patients with poor control of hypertension; 6) Patients with infectious pneumonia, non infectious pneumonia, interstitial pneumonia and other patients who need to use corticosteroids; 7) Patients with chronic autoimmune diseases, such as systemic lupus erythematosus, etc; 8) Other situations that the researchers do not think suitable for inclusion.

Design outcomes

Primary

Measure	Time frame
Overall survival, OS;?Progression Free Survival, PFS;	—

Secondary

Measure	Time frame
Objective response rate, ORR; including CR+PR;Disease Control Rate, DCR; including CR+PR+SD);	—

Countries

China

Contacts

Public ContactShujian Chang

Department of Oncology, The Affiliated Hospital of Jiangnan University

changsj882652@sina.com+86 18861530277

Outcome results

None listed

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