Efficacy and safety of anti-PD-1 monoclonal antibody with concurrent chemoradiotherapy for potentially resectable pancreatic cancer

Conditions

Pancreatic cancer

Jiayao Ni, Yi Sun, Hao Cheng, Xinyuan Bai, Fan Tong et al. (24 authors)

2026-02-04

10.1158/1078-0432.c.8289899

Tislelizumab and hypofractionated radiotherapy plus nab-paclitaxel/gemcitabine as conversion therapy for BRPC/LAPC: A Phase II trial with dynamic biomarker monitoring.

Ni J, Sun Y, Cheng H, Bai X, Tong F, Zhang X, Wang X, Mao L, Li G, Shen S, Kong W, He J, Li A, Chen J, Tang M, Chen B, Li Q, Gu Q, Lu Z, Chen D, Sha H, Liu B, Qiu Y, Du J.

2025-12-01

10.1158/1078-0432.ccr-25-2461

PD-1 blockade plus chemotherapy followed by concurrent SBRT with SIB as preoperative therapy for patients with borderline resectable and locally advanced pancreatic cancer: A biomolecular exploratory, single-arm phase II clinical trial.

Juan Du, Changchang Lu, Liang Mao, Weiwei Kong, Yahui Zhu et al. (11 authors)

Journal of Clinical Oncology2023-06-01

10.1200/jco.2023.41.16_suppl.4159

Study protocol for a prospective, open-label, single-arm, phase II study on the combination of tislelizumab, nab-paclitaxel, gemcitabine, and concurrent radiotherapy as the induction therapy for patients with locally advanced and borderline resectable pancreatic cancer

Changchang Lu, Yahui Zhu, Weiwei Kong, Ju Dong Yang, Linxi Zhu et al. (18 authors)

Frontiers in Oncology2022-08-184 citations

10.3389/fonc.2022.879661

Interventions

Combined therapy group:PD-1 mAb, nab-paclitaxel, gemcitabine and radiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subjects with age >= 18 years and ECoG score of 0-1; 2. Subjects with pancreatic cancer confirmed by histology or cytology; 3. The patients with potentially resectable pancreatic cancer were imaged; 4. The subjects should meet the following hematological indexes: Neutrophil count >= One point five x 10^9/L Hemoglobin >= 10g / dl Platelet count >= 100 x 10^9 / L 5. The subjects should meet the following biochemical indicators: Total bilirubin = 60ml / min. 6. Subjects of childbearing age need to take appropriate protective measures (contraceptive measures or other methods of birth control) before entering the group and during the test: 7. Subjects who have signed informed consent; 8. Subjects who were able to follow the protocol and follow-up procedures.

Exclusion criteria

Exclusion criteria: 1. Patients who have received systematic anti-tumor treatment. 2. Patients with previous history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (TA and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment). 3. Patients with active bacterial or fungal infection (> = level 2 of NCI-CTC, 3rd Edition). 4. Patients with HIV, HCV, HBV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases considered by researchers to be out of the group. 5. Patients with autoimmune diseases or immune defects who are treated with immunosuppressive drugs. 6. Pregnant and lactating women. Pregnant women of childbearing age must be tested negative within 7 days before entering the group. 7. Patients with drug abuse, clinical or psychological or social factors make informed consent or research implementation affected. 8. Patients who may be allergic to PD-1 monoclonal antibody immunotherapy drugs.

Design outcomes

Primary

Measure	Time frame
ORR;R0 resection rate;	—

Secondary

Measure	Time frame
mOS;mPFS;DCR;Pathological grade of tumor tissue after neoadjuvant therapy;Adverse reaction;	—

Countries

China

Contacts

Public ContactJuan Du

Nanjing Drum Tower Hospital

dujuanglyy@163.com+86 13951826526

Outcome results

None listed