전이성 췌장암 1차 치료로서 TQB2916 주사제와 젬시타빈 및 알부민 결합 파클리탁셀 병용요법에 대한 임상시험¶

A Clinical Study on the First-line Treatment of Metastatic Pancreatic Cancer With TQB2916 Injection Combined With Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (Albumin-bound Type)

안내

이 페이지는 자동 수집·AI 요약된 정보입니다. 의료 조언이 아니며, 치료 결정은 반드시 담당 의료진과 상의하세요. 응급 상황은 응급 가이드 또는 119.

항목	내용
등록번호	NCT06962267
상태	모집 중
단계	2상
시험 약물/중재	TQB2916 Injection, Chemotherapy
대상 질환	Pancreatic Cancer
스폰서	Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
연령·성별	18 Years ~ 75 Years · ALL
목표 인원	50
시작 / 1차 완료 예정	2025-04-18 / 2027-08
국내 실시기관	없음
실시 국가	1개국, 기관 1곳 (China)
결과 게시	아니오
최근 갱신	2025-05-08

문의처 (등록된 중앙 연락처)¶

Yi Ba, Doctor 13752157916 Bayi@tjmuch.com

국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내

시험 개요¶

이 임상시험은 전이성 췌장암(metastatic pancreatic cancer) 환자 50명을 대상으로 TQB2916 주사제, gemcitabine(젬시타빈), albumin-bound paclitaxel(알부민 결합 파클리탁셀) 병용요법의 유효성과 안전성을 평가합니다. 단일군, 공개 오픈라벨(open-label) 디자인으로 진행됩니다. 현재 환자를 모집 중이며, 단계는 2상(PHASE2)입니다. 초록에 명시되지 않음.

목표 환자 수는 50명입니다.
대상 질환은 전이성 췌장암입니다.
중재 방법은 TQB2916 주사제와 항암화학요법(Chemotherapy) 병용입니다.

참여 조건 (AI 정리, 원문 확인 필요)¶

선정 기준: - 본 연구에 자발적으로 참여하고 동의서에 서명한 자 - 연령: 18세에서 75세 - 조직학적 또는 세포학적으로 확인된 췌장관선암(pancreatic ductal adenocarcinoma) - RECIST 1.1 기준에 따른 측정 가능한 병변이 최소 1개 이상 있는 자 - 전신 항암 치료를 받은 적이 없는 자 - ECOG 수행능력 평가 점수 0-1점이며, 예상 생존 기간이 3개월 이상인 자 제외 기준: - 5년 이내에 다른 악성 종양이 있었거나 동시에 앓고 있는 자(완치된 피부 기저세포암 및 자궁경부 상피내암 등 예외 규정 있음) - 탈모를 제외하고 이전 치료로 인한 CTCAE 1등급을 초과하는 회복되지 않은 독성 반응이 있는 자 - 첫 투여 28일 이내에 주요 수술, 심각한 외상성 손상, 치유되지 않은 상처나 골절이 있는 자 - 첫 투여 4주 이내에 CTCAE 3등급 이상의 출혈 사건이 있었던 자 - 첫 투여 6개월 이내에 동정맥 혈전증 사건이 있었던 자

선정/제외 기준 원문 (영어)

Inclusion Criteria:

The subjects voluntarily joined this study and signed the informed consent form;
Age: 18-75 years old (the time of signing the informed consent form, including the critical value);
Pancreatic ductal adenocarcinoma confirmed by tissue or cytology (excluding other mixed pancreatic cancers);
Have at least one measurable lesion according to the RECIST 1.1 standard;
Without any systematic anti-tumor treatment;
The Eastern Cooperative Oncology Group (ECOG) score is 0-1, and the expected survival period is more than 3 months;
The main organs function well;
Patients must adopt reliable contraceptive measures during the study period and within 6 months after the end of the study period;The serum pregnancy test must be negative within 7 days before enrollment in the study, and the subjects must be non-lactating.

Exclusion Criteria:

Comorbid diseases and medical history:
Within 5 years, the subject has had or simultaneously suffered from other malignant tumors (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);Patients with other malignant tumors, but the following two situations can be enrolled: other malignant tumors treated by single surgery, achieving R0 resection and no recurrence or metastasis within 5 years;Cured cervical carcinoma in situ, cutaneous basal cell carcinoma, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor-infiltrating basement membrane)];
Unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 caused by any previous treatment, excluding alopecia;
Have received major surgical treatment, obvious traumatic injury, or have long-term unhealed wounds or fractures within 28 days before the first medication;
Patients who experienced any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first administration;
Those who have experienced hyperarterial/venous thrombotic events within 6 months before the first administration, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism.
hepatitis B virus (HBV) virus-infected individuals cannot receive regular antiviral treatment throughout the entire course.Hcv-infected individuals (HCV Ab or HCV RNA positive) : Researchers determine that they are in an unstable state or need to continue antiviral treatment. They cannot receive regular antiviral treatment in the study.
Active syphilis patients;
Those with a history of abuse of psychotropic drugs and who are unable to quit or have mental disorders;
Symptomatic interstitial lung disease, as well as conditions that may cause drug-induced pulmonary toxicity or associated pneumonia;
Subjects with any severe and/or uncontrolled diseases.
Tumor-related symptoms and treatments:
Imaging (CT or MRI) shows that the tumor has invaded around important blood vessels, and the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive hemorrhage during the subsequent study period;
Subjects with known central nervous system metastases and/or cancerous meningitis;
Uncontrolled pleural effusion, pericardial effusion or ascites that still require repeated drainage (as determined by the researcher).
Research treatment-related:
There is a history of severe allergy to large molecule drugs in the past, or allergy to known components of TQB2916 injection;
Those who received chronic treatment with systemic hormones or other immunosuppressants (dose >10mg/ day prednisone or other equivalent therapeutic hormones) within 28 days before the start of administration in this study and still need to continue using hormones or immunosuppressants within 2 weeks after the first trial administration (except temporarily);
The history of attenuated live vaccine inoculation within 28 days before the start of the study treatment or the planned attenuated live vaccine inoculation during the study period;
An active autoimmune disease that required systemic treatment (such as the use of disease-relieving drugs, corticosteroids or immunosuppressants) occurred within 2 years prior to the first medication.
Participated in clinical trials of other anti-tumor drugs within 28 days before the start of administration in this study;
Subjects who, based on the researcher's judgment, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered to have other reasons and are not suitable for enrollment.

출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06

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