pancreatic ductal adenocarcinoma
Conditions
Interventions
Test group:HRS-4642+Nimotuzumab
Sponsors
West China Hospital,Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients must meet all of the following criteria to be enrolled in this study. 1) Male and female subjects aged 18-75 years (including 18 and 75 years); 2. Pancreatic ductal adenocarcinoma confirmed by pathology (histology) or cytology, identified as a carrier of KRAS G12D mutation; 3. Metastatic pancreatic ductal adenocarcinoma that progresses or is intolerant after first-line and above system therapy, occurring within 6 months of adjuvant therapy Patients with recurrence or metastasis may also be included in the study; 4. At the time of study enrollment, at least one radiographic diagnosis was measurable according to the solid tumor efficacy evaluation criteria (RECIST1.1) Lesions (lesion diameter >=10 mm and lymph node diameter >=15 mm according to CT or MRI evaluation); 5. Physical condition score ECOG score 0-2 points; 6. Expected survival >= 12 weeks; 7. Major organ function is normal, that is, meet the following criteria: (1) blood routine (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors correction) : a. Hb >=90 g/L; b. ANC >=1.5×10^9/L; c. PLT>=75×10^9/L; d. WBC>=3.0×10^9/L; (2) Blood biochemistry: a. TBIL =50 mL/min;d. Plasma albumin >=30g/L; (3) Coagulation routine: International standardized ratio (INR) =50%, QTcF >= 450 msec (male) or 1+, urine protein measurement should be collected for 24 hours, and the total amount should be <=1.0g; 8. The AE caused by previous antitumor therapy must be restored to a level of <= Grade 1 (CTCAE v5.0) or the level specified in the exclusion criteria If the investigator judged that NCI-CTCAE= grade 2 and there was no safety risk to the subjects, they could be enrolled, such as receiving immune checkpoint suppression Formulation-treated subjects with type 1 diabetes and hypothyroidism who are stable after hormone replacement therapy; 9. Fertile female subjects must undergo a serum pregnancy test within 7 days before the first dose, and the result is negative; And must be non-lactating. A fertile female subject and a male subject whose partner is a woman of childbearing age must consent to the sign-off Adherence to contraception began with informed consent until 30 days after the last administration of the trial drug (subjects receiving HRS-4642) Require; 10. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients will not be admitted to the study if they meet any of the following criteria: 1) The patient had previously used KRAS inhibitors or targeted EGFR therapy; 2. known allergy to the investigational drug or any of its components; 3. Systemic antitumor therapy, including chemotherapy, targeted therapy and immunotherapy, has been received within 28 days before the first dose (including no treatment) City of clinical investigational drugs or treatments), except for the following: oral fluorouracil and small molecule targeted drugs for first use The first 14 days of the study of the drug or the five half-lives of the drug (whichever is longer). Chinese medicines with anti-tumor indications are Within 14 days before the first use of the investigational drug; Surgical treatment (except diagnostic surgery) within 28 days prior to initial dosing; The first Patients who received local treatment such as radiotherapy, intervention or ablation within 14 days before secondary administration; 4. Prior or co-existing other malignancies, unless complete remission was achieved at least 2 years prior to screening and not during the study period Basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical cancer in situ, cancer of the skin that requires or is not expected to require other treatment Local prostate cancer, breast ductal carcinoma in situ after radical surgery, papillary thyroid cancer (non-metastatic prostate cancer or breast cancer allowed) Hormone therapy for adenocarcinoma); 5. accompanied by untreated or active central nervous system (CNS) tumor metastasis. Have a history of meningeal metastasis or current meninges 15 Transfer the subject. At least 2 weeks before the first dose, if the subject has received adequate local treatment for CNS metastasis Treatment (surgery or radiation) without the need for hormone therapy and neurological return to baseline (associated with CNS treatment) Except for remaining signs or symptoms), can be included in the group; 6. Patients with severe cardiovascular thromboembolism (e.g., myocardial infarction, no.) within 6 months prior to study entry Stable angina pectoris, stroke), NYHA grade 2 or above cardiac dysfunction, and clinically significant supraventricular or ventricular arrhythmias Patients who require clinical intervention; 7. Study the presence of digestive tract obstruction or the presence of signs and symptoms of digestive tract obstruction within 6 months before the start of treatment, but if it has been done Screening can be performed with surgical treatment and complete removal of obstruction. 8) Bleeding events of esophageal and gastric varices caused by portal hypertension occurred within 3 months before the first administration; 9. Had undergone a gastroscopy within 3 months prior to the first dose indicating severe (G3) varicose veins without treatment or without treatment Recover; Portal hypertension was present (including radiographic evidence of splenomegaly) and the investigators determined that admission to the study caused a larger risk Bleeding risk; 10. Advanced patients who are symptomatic, have spread to the internal organs, and are at risk of developing life-threatening complications in the short term (including Patients with uncontrolled exudation [chest, pericardium, abdominal cavity]; If effusion drainage is performed, at least stable after drainage Patients who have been diagnosed for 2 weeks can be enrolled in the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DCR;Duration of Response, DoR;Progression Free Survival, PFS;Overall Survival, OS;Tumor markers (CA19-9, CA125, CEA); | — |
Countries
China
Contacts
Public ContactDan Cao
West China Hospital,Sichuan University
Outcome results
None listed