pancreatic cancer
Conditions
Interventions
Treatment Group:short-term radiotherapy combined with neoadjuvant chemotherapy and PD1 inhibitor
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-70 years, regardless of sex. (2) Histologically diagnosed as pancreatic cancer, initially treated (without surgery, radiotherapy, chemotherapy or targeted therapy). (3) Borderline resectable pancreatic cancer: the tumor has no distant metastasis; the superior mesenteric vein-portal vein tumor invades segmental stenosis, distortion or occlusion, but can be safely reconstructed after resection; gastroduodenal artery invasion reaches the level of hepatic artery, but does not involve celiac trunk; tumor invasion of superior mesenteric artery does not exceed 180 °of circumference. (4) Hemoglobin (Hb) >=9 g/dL); leukocyte (WBC) >= 3 x 10 9/L; neutrophil (ANC) >= 1.5 x 10 9/L; platelet (Pt)>= 100x10 ^9/L; bilirubin = 50mL/min. Thyroid stimulating hormone (TSH) <= ULN (if abnormal, you should also refer to the levels of T3 and T4. If T3 and T4 are normal, you can also be included in the group.). (5) Fertile men or women were willing to use contraception in the trial; physical condition score ECOG 0-1. (6) The patient or family member agrees to participate in this study and sign the informed consent form. (7) No severe abnormalities of blood system, heart, lung, liver, kidney and immune deficiency were found. (8) No other serious cardiopulmonary diseases, etc. (9) No contraindications for the use of paclitaxel (albumin-bound) and gemcitabine.
Exclusion criteria
Exclusion criteria: (1) Patients have previously been exposed to any anti-PD-1 or anti-PD-L1 antibodies. (2) Women who are breastfeeding, pregnant or preparing for pregnancy. (3) Corticosteroids (equivalent to prednisone > 10 mg/ days) or other immunosuppressants should be given within 2 weeks before the administration of the study drug. (4) Active, known or suspected autoimmune disease or a history of the disease in the past 2 years (vitiligo, psoriasis, alopecia or Graves' disease that did not require systematic treatment in the past 2 years, patients with hypothyroidism who only need thyroid hormone replacement therapy and type I diabetes patients who only need insulin replacement therapy can be enrolled in the group. (5) Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; HIV infection, or active hepatitis B or hepatitis C (active hepatitis B reference: HBV DNA >= 104copies / ml; active hepatitis C reference: HCV RN >= 103copies / ml). (6) Interstitial lung disease (both past and present), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI. (7) Allergic constitution and multi-drug allergy. (8) Those who have severe heart, lung, liver and kidney dysfunction, such as decompensated heart, lung, kidney, liver and other major organ dysfunction, failure or poor blood glucose control, are unable to tolerate chemotherapy. (9) Severe infection. (10) Patients with cognitive impairment or poor compliance with chemotherapy determined by researchers. (11) Those who participated in other clinical trials within 30 days before joining the group. (12) Those who are considered by the researchers to be unsuitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Objective remission rate;CA199; | — |
Countries
China
Contacts
Public ContactZhang Tao, Xue Jun
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed