Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases : A Prospective, Single-Arm, Phase II Study

NCT ID: NCT06404840

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-06
• Study Completion Date: 2026-05-31

Brief Summary

Patients with PCLM account for the majority of our department's pancreatic cancer cases and often have limited surgical options due to the aggressive nature of their tumors. For those with good performance status (ECOG PS 0-1), NCCN recommends gemcitabine + nab-paclitaxel (AG). Though nimotuzumab combined with gemcitabine improves survival, there remains scarce clinical data regarding its efficacy in conjunction with AG for treating PCLM. This study aims to evaluate the safety and efficacy of incorporating nimotuzumab with AG for PCLM.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AG+nimotuzumab

Pts with potentially resectable, treatment-naïve PCLM received nimotuzumab (400 mg, iv, d1, qw) and AG chemotherapy (gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle).

Group Type: EXPERIMENTAL

nimotuzumab

Intervention Type: DRUG

nimotuzumab (400 mg, iv, d1, qw)

AG chemotherapy

Intervention Type: DRUG

(gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle)

Interventions

nimotuzumab

nimotuzumab (400 mg, iv, d1, qw)

Intervention Type: DRUG

AG chemotherapy

(gemcitabine 1000mg/m², Nab-paclitaxel 125mg/m², d1, d8, 21d cycle)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1) Age: 18-75 years old; 2) Physical strength KPS ≥ 60 points; 3) Pancreatic ductal epithelial adenocarcinoma with liver metastasis that has been diagnosed by pathological histology or cytology and is not suitable for radical radiotherapy or surgical treatment (should be at least 6 months away from the last adjuvant chemotherapy); 4) According to the RECIST 1.1 evaluation criteria, there should be at least one measurable and evaluable objective lesion (the longest diameter of the target lesion on spiral CT examination should be ≥ 10mm; if there is only lymph node metastasis, the shortest diameter should be ≥ 15mm); 5) Expected survival time ≥ 3 months; 6) Serum AST/ALT ≤ 5 times ULN; Total bilirubin ≤ 3 times ULN; Absolute count of granulocytes ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Hemoglobin ≥ 90 g/L; Creatinine clearance rate ≥ 60ml/min; 7) Voluntarily participate in this study, sign an informed consent form, and have good compliance; 8) Patients of childbearing age and their spouses are willing to take contraceptive measures.

Exclusion Criteria

• 1) Prior to this study, the following treatments were received:

1. Antitumor chemotherapy and molecular targeted therapy as a palliative measure

2. The target lesion has undergone radiotherapy without any progression

3. Within 4 weeks or currently participating in other therapeutic/intervention clinical trials 2) Received major surgery within 4 weeks; 3) Existing brain metastasis or leptomeningeal metastasis; 4) Have a history of other malignancies other than pancreatic cancer (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for 5 years); 5) Merge symptomatic abdominal fluid that requires clinical treatment; 6) Accompanied by other serious illnesses, including but not limited to:

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1. Uncontrollable congestive heart failure (NYHA grade III or IV, see Appendix III), unstable angina, poorly controlled arrhythmias, uncontrolled moderate to high blood pressure (SBP>160mmHg or DBP>100mmHg)

2. Active infection

3. Difficult to control diabetes

4. Mental illnesses that affect informed consent and/or adherence to protocols

5. HIV infection

• Failure to conduct effectiveness and/or safety evaluations; Serious violation of the protocol: While participating in this study, other chemotherapy drugs and/or modern Chinese medicine preparations with anti-cancer indications were used for treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Huikai Li, Doctor

Role: primary

tjchlhk@126.com

18622228639

Yang Liu, MD

Role: backup

tjchlhk@126.com

17694950696

Other Identifiers

AG plus Nimotuzumab

Identifier Type: -

Identifier Source: org_study_id