Actively Recruiting
Phase II Trial Evaluating TQB2102 Injection with Benmelstobart or Penpulimab Plus Chemotherapy in HER2-Positive Unresectable, Locally Advanced, Recurrent, or Metastatic Gastroesophageal Adenocarcinoma
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-07-30
204
Participants Needed
39
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TQB2102 for injection, a new antibody-coupled drug that targets two different parts of the HER2 protein on tumor cells. This study focuses on patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. The trial aims to assess the effectiveness and safety of TQB2102 combined with benmelstobart or penpulimab, with or without chemotherapy, in this patient group. This is a Phase II randomized study sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive TQB2102 for injection and either benmelstobart or penpulimab, both given intravenously every three weeks. Chemotherapy is taken orally from Day 1 to Day 15 in each 21-day treatment cycle. There are three study groups, each involving different combinations and doses of TQB2102, benmelstobart, penpulimab, and chemotherapy. Treatment continues through multiple cycles as determined by the study protocol. During the study, participants undergo regular assessments including scans and tests to measure tumor response and disease progression. Researchers monitor outcomes like the objective response rate, progression-free survival, duration of response, overall survival, and any adverse events. The study includes follow-up periods to track safety and effectiveness, with an average observation of up to three years. Participants are closely monitored throughout the treatment and follow-up phases for their health and response to therapy.
CONDITIONS
Brief Title
A Clinical Trial Evaluating TQB2102 for Injection in Combination With Behmosubaisumab/Payamprolizumab With or Without Chemotherapy in Unresectable Locally Advanced, Recurrent, or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Gastroesophageal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 3 months
- Histopathologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma
- HER2 expression confirmed as Immunohistochemistry (IHC) 3+ or IHC 2+ with In Situ Hybridization (ISH) positivity in tumor tissue
- Ability to provide previous PD-L1 test results or sufficient tumor tissue for PD-L1 testing
- No prior systemic therapy for locally advanced or metastatic gastric cancer or recurrence/metastasis at least 6 months after prior adjuvant/neoadjuvant therapy
- At least one measurable lesion per RECIST 1.1 criteria
- Adequate main organ function
- Male or female patients not planning pregnancy and willing to use effective contraception during and for at least 6 months after treatment
You will not qualify if you...
- Concurrent secondary malignancy or other malignancy with no evidence of disease for less than 5 years
- Uncontrollable toxic reactions above grade 1 from prior therapy, excluding alopecia
- Major surgery, significant injury, or unhealed wounds within 28 days before first dose
- History or presence of interstitial lung disease or pneumonia requiring steroids
- Arterial or venous thrombotic events within 6 months before first dose
- History of psychiatric drug abuse or mental disorders preventing quitting
- Severe or uncontrolled diseases increasing study risk
- Recent treatment with other antitumor drugs within 4 weeks or Chinese proprietary medicine with antitumor indication within 2 weeks
- Recent severe bleeding events grade 3 or higher
- Known central nervous system metastases or carcinomatous meningitis
- Severe bone damage or spinal cord compression due to tumor metastases
- Live attenuated vaccination within 28 days before first dose or planned during study
- Severe allergy to study drugs or components
- Active autoimmune disease requiring systemic therapy within 2 years
- Immunodeficiency or recent immunosuppressive therapy within 2 weeks before study
- Participation in other anti-tumor drug trials within 4 weeks before first dose
- Unstable or serious medical conditions increasing risk-benefit ratio
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive intravenous infusions of TQB2102 and either Bemarituzumab or Penpulimab every three weeks, alongside oral chemotherapy from Day 1 to Day 15 in each 21-day cycle.
Infusions every 3 weeks with oral chemotherapy for the first 15 days of each cycle
Duration - Up to 3 years after treatment completion
Participants are monitored for safety, adverse events, and survival outcomes after treatment ends.
Visits as needed for safety and survival assessments
Trial Site Locations
Total: 39 locations
1
Fuyang Cancer Hospital
Fuyang, Anhui, China, 23600
Not Yet Recruiting
2
Lu'an People's Hospital
Lu'an, Anhui, China, 237000
Not Yet Recruiting
3
Maanshan People's Hospital
Maanshan, Anhui, China, 243000
Actively Recruiting
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
5
The first affiliated hospital of chongqing medical university
Chongqing, Chongqing Municipality, China, 400016
Not Yet Recruiting
6
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
7
Gansu Prouincial Cancer Hospital
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
8
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China, 733099
Not Yet Recruiting
9
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
10
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
11
Jiangmen Central Hospital
Jiangmen, Guangdong, China, 529000
Not Yet Recruiting
12
Meizhou People's Hospital
Meizhou, Guangdong, China, 514031
Not Yet Recruiting
13
The Second Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, China, 541004
Not Yet Recruiting
14
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Not Yet Recruiting
15
The first affiliated hospital of hainan medical university
Haikou, Hainan, China, 570102
Not Yet Recruiting
16
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050010
Not Yet Recruiting
17
Tangshan People's Hospital
Tangshan, Hebei, China, 063001
Not Yet Recruiting
18
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
19
Anyang Cancer Hospital
Anyang, Henan, China, 455000
Not Yet Recruiting
20
The 1st Affiliated Hospital of He'nan University of Science and Technology
Luoyang, Henan, China, 471000
Not Yet Recruiting
21
Puyang Oilfield General Hospital
Puyang, Henan, China, 457001
Not Yet Recruiting
22
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
23
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
Not Yet Recruiting
24
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441000
Not Yet Recruiting
25
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
26
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, China, 410000
Not Yet Recruiting
27
NanJing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
28
Jiangning Hospital of Nanjing City
Nanjing, Jiangsu, China, 211100
Not Yet Recruiting
29
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225009
Not Yet Recruiting
30
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Not Yet Recruiting
31
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 264000
Not Yet Recruiting
32
Fudan university shanghai cancer center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
33
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200120
Not Yet Recruiting
34
Shanxi Cancer hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
35
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China, 710000
Not Yet Recruiting
36
Nanchong Central Hospital
Nanchong, Sichuan, China, 637000
Not Yet Recruiting
37
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300202
Not Yet Recruiting
38
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, Xinjiang, China, 810000
Not Yet Recruiting
39
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
R
Ruihua Xu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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