HER2 IHC3+ Advanced Colorectal CancerPhase 3NCT07483684
A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs
A Phase 3 study testing TQB2102 Injection and Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets in people with HER2 IHC3+ Advanced Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 48 sites in China.
Trial summary
This is a Phase III, randomized, open-label, active-controlled, multicenter study designed to evaluate the efficacy and safety of Injection TQB2102 compared with investigator's choice of treatment in subjects with Human Epidermal Growth Factor Receptor 2 (HER2) ImmunoHistoChemistry score 3 (IHC3+) advanced colorectal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2 IHC3+ Advanced Colorectal Cancer
- What is being tested?
- TQB2102 Injection and Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 48 sitesChina
- Study dates
- Mar 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject voluntarily participates in this study, signs the informed consent form, and has good compliance.
- Aged 18 to 75 years old (calculated as of the date of signing the informed consent form).
- Subjects with histologically or cytologically confirmed advanced colorectal cancer.
- The subject has confirmed HER2 IHC3+ status in tumor tissue, as determined by the central laboratory designated by the sponsor.
- The subject must provide a sufficient quantity of qualified tumor specimens (fresh or archived samples collected within the past 3 years from primary or metastatic lesions) for central laboratory testing of HER2 status.
- Advanced colorectal cancer that has progressed on or been intolerant to at least 2 prior lines of standard therapy (defined as disease progression or intolerable toxicity during or within 3 months after the last standard therapy).
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Expected survival of greater than 12 weeks.
- Presence of at least one measurable lesion as confirmed by RECIST 1.1 criteria.
- Laboratory tests must meet criteria
- Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the study ends, and have a negative serum or urine pregnancy test within 7 days prior to study entry. Men must agree to use effective contraception during the study and for 6 months after the study ends.
Who cannot join
- A history of other malignant tumors within 3 years prior to the first dose, or concurrent malignant tumors at screening. Subjects are eligible for enrollment if they meet one of the following two conditions:
- Other malignant tumors treated with curative intent via a single surgical procedure, with disease-free survival (DFS) maintained for 5 consecutive years;
- A history of cured carcinoma in situ of the cervix, non-melanoma skin cancer, or superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)].
- Presence of diseases that affect intravenous injection or venous blood collection, or factors that impair oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction, etc.).
- Failure of adverse reactions from prior treatments to resolve to ≤ Grade 1 per CTCAE v5.0, with the following exceptions: Grade 2 alopecia, Grade 2 peripheral neurotoxicity, Grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, type 1 diabetes mellitus and hypothyroidism stabilized with hormone replacement therapy, and other toxicities judged by the investigator to pose no safety risks.
- Receipt of major surgical treatment, significant traumatic injury within 4 weeks prior to the first dose; or planned major surgery during the study period (excluding surgeries specified in the protocol); or presence of unhealed wounds or fractures for a prolonged period.
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- Clinically significant tumor bleeding or perforation within 1 month prior to the first dose; or any bleeding event ≥ Grade 3 per CTCAE v5.0; or subjects with bleeding or coagulation disorders receiving warfarin, aspirin, or other antiplatelet agents (excluding maintenance doses: aspirin ≤ 100 mg/day, clopidogrel ≤ 75 mg/day); or subjects with a history or signs of bleeding deemed ineligible by the investigator.
- A history of thrombotic or embolic events within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis (DVT) [excluding subjects with isolated calf vein thrombosis ≤ 7 mm in diameter, ≤ 5 cm in length, not involving ≥ 2 veins, and assessed by the investigator as having no risk of thrombus progression], and pulmonary embolism, etc.
- Presence of major cardiovascular diseases.
- A history of decompensated liver cirrhosis or hepatic encephalopathy.
- Subjects with active chronic hepatitis B or active chronic hepatitis C. Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening must undergo additional testing for Hepatitis B Virus (HBV) DNA titer or HCV RNA quantification.
- Active syphilis infection requiring treatment.
- A history of (non-infectious) pneumonitis/interstitial lung disease requiring corticosteroid therapy; or current diagnosis of non-infectious pneumonitis/interstitial lung disease; or hospitalization for any active infection or receipt of therapeutic antibiotics within 4 weeks prior to the start of study treatment, including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Active or uncontrolled severe infection (≥ Grade 2 infection per CTCAE v5.0).
- A history of psychoactive substance abuse with inability to abstain, or presence of mental disorders.
- A history of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Tumor-related symptoms and treatments.
- Known hypersensitivity or allergic reaction to any study drug or its excipients.
- Prior receipt of anti-HER2 antibody-drug conjugate (ADC) therapy.
- Receipt of any anticancer therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) or any other investigational drug therapy within 4 weeks or 5 half-lives prior to the first dose of this study, whichever is shorter.
- Pregnant or lactating subjects.
- Vaccination with live-attenuated vaccines within 28 days prior to the start of study treatment, or inactivated vaccines within 7 days prior; or planned vaccination during the study period.
- Any other condition judged by the investigator to pose a serious risk to subject safety or interfere with the subject's completion of the study.
Trial locations and contacts
48 sites in 1 country. Contact the study team or a site near you to ask about taking part.
48 sites in 1 country
China48 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Wei Deng, Doctor, 13426136152, dengweiwei@126.com
Jilin Cancer Hospital
Changchun, Jilin, 130000
Haifeng Liu, Master, 0431-80596336, HFLIU2025@163.com
Hunan Cancer Hospital
Changsha, Hunan, 410000
Zhenyang Liu, Doctor, 18673181133, 18673181133@163.com
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Yawen Gao, Doctor, 18673194699, 2948390593@qq.com
Sichuan Academy of Medical Science&Sichuan Provincial People' Hospital
Chengdu, Sichuan, 610000
Hao Liu, Doctor, 18981838378, 604083933@qq.com
Sichuan Provincial Cancer Hospital (Sichuan Provincial Cancer Prevention and Treatment Center of the Second People's Hospital of Sichuan Province)
Chengdu, Sichuan, 610041
Yongdong Jin, Doctor, 18908190337, cccjin@163.com
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Longhao Li, Doctor, 18375807001, llh@hospital.cqmu.edu.cn
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Rongbo Lin, Bachelor, 13705919382, rongbo_lin@163.com
The first affiliated hostpital of guangzhou medical university (national center for respiratory medicine)
Guangzhou, Guangdong, 510000
Jinsong Chen, Doctor, 15920379816, hychenjs@126.com
Sun Yat-sen university cancer center
Guangzhou, Guangdong, 510050
Ruihua Xu, Doctor, 020-87343468, xurh@syscc.org.cn
The People's Hospital of Guizhou Province
Guiyang, Guizhou, 550002
Shisheng Tan, Doctor, 13809427655, tssh18018@126.com
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570311
Erxia He, Master, 13158980546, heerxia@163.com
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Haizhou Lou, Doctor, 19957173556, Louhz09@163.com
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310017
Ying Yuan, Doctor, 13858193601, yuanying1999@zju.edu.cn
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, 150006
Yan Liu, Doctor, 13845078500, 1953786691@qq.com
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
Guangyu Wang, Doctor, 18249038966, wangguangyu03@163.com
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000
Shuanghu Yuan, Doctor, 13853106916, Yuanshuanghu@sina.com
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000
Yifu He, Doctor, 18963789042, 834638033@qq.com
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jing Hao, Doctor, 18560082857, hedi0084@hotmail.com
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, 250117
Zuoxing Niu, Master, 13506413687, nzxsdth@163.com
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029
Junye Wang, Bachelor, 18678766866, jiningwangjunye@163.com
Lei Han, Master, 18678766981, hanleixxf@126.com
Yunnan Cancer Hospital
Kunming, Yunnan, 650000
Xinyi Cai, Doctor, 13888024272, 1816272355@qq.com
Cancer Hospital Chinese Academy pf Medical Seciences
Langfang, Hebei, 650000
Yongkun Sun, Doctor, 13141276041, hsunyk@126.com
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Zhihu Li, Master, 18993042850, zhihu_li666@163.com
Linyi people's Hospital
Linyi, Shandong, 276000
Jinling Zhang, Master, 17661666010, jinlingzhang_931@163.com
Linyi Cancer Hospital
Linyi, Shandong, 276034
Zhen Li, Bachelor, 13869908100, lizhensdly@126.com
Meizhou People's Hospital(Huangtang Hospital) Meizhou Academy of Medical Sciences
Meizhou, Guangdong, 514000
Xiwen Huang, Bachelor, 13751952289, 811253076@qq.com
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330000
Xiaodong Peng, Master, 13755692883, 710749456@qq.com
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000
Liangjun Zhu, Doctor, 13505199123, Zhulj98@foxmall.com
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Jing Sun, Doctor, 13914704178, sunj@njmu.edu.cn
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530000
Xiaoli Liao, Doctor, 13978627806, nllxl@163.com
ZhongShan Hospital
Shanghai, Shanghai Municipality, 200030
Tianshu Liu, Doctor, 13681973996, liu.tianshu@zs-hospital.sh.cn
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Junli Xue, Doctor, 13764694939, 13764694939@163.com
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Junjie Peng, Doctor, 18017317122, junjiepeng67@163.com
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801
Jingdong Zhang, Master, 13804027878, 13804027878@163.com
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110801
Xiujuan Qu, Doctor, 13604031355, qu_xiujuan@hotmail.com
Introduction Of Shanxi Cancer Hospital
Taiyuan, Shanxi, 300000
Mudan Yang, Master, 13834622689, 53473139@qq.com
13803433331 Han, Master, Hongxia, yangmd6000@163.com
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 300010
Yusheng Wang, Doctor, 13834646436, wangyusheng1972@163.com
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, 300121
Xipeng Zhang, Bachelor, 13802008480, zhxp1011@163.com
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Yanli Qu, Master, 18160627936, quyanli73@163.com
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xinjun Liang, Doctor, 13995607152, doctorlxj@163.com
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital )
Xi'an, Shaanxi, 710004
Hui Guo, Doctor, 13572824106, guohui@xjtufh.edu.cn
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710061
Jun Bai, Doctor, 13186055863, edgemen@163.com
The First Affiliated Hospital of Xi 'An Jiaotong University
Xi'an, Shaanxi, 710061
Aili Suo, Doctor, 18991232561, Ailisuo@mail.xjtu.edu.cn
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Jiayi Li, Master, 13799792820, ljy778848@qq.com
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
Yushuang Luo, Doctor, 13897208152, 13897208152@163.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Shuiling Jin, Doctor, 13838008938, fccjinsl@zzu.edu.cn
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Xiaobing Chen, Doctor, 13937100233, 2290773710@qq.com
About this study
Official title: A Randomized, Open-Label, Active-Controlled, Multicenter Phase III Clinical Study to Evaluate Injection TQB2102 Versus Investigator's Choice of Treatment Regimens in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs
This is a Phase III, randomized, open-label, active-controlled, multicenter study designed to evaluate the efficacy and safety of Injection TQB2102 compared with investigator's choice of treatment in subjects with Human Epidermal Growth Factor Receptor 2 (HER2) ImmunoHistoChemistry score 3 (IHC3+) advanced colorectal cancer who have failed prior treatment with oxaliplatin, irinotecan, and fluoropyrimidine-based regimens.
The primary endpoint of this study is progression-free survival (PFS) as assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). Other secondary endpoints include investigator-assessed PFS, objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), safety, and quality of life scores.
Approximately 142 subjects are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the experimental group or the control group.
- Conditions
- HER2 IHC3+ Advanced Colorectal Cancer
- Being tested
- TQB2102 Injection, Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2102 InjectionDrug
TQB2102 Injection is a next-generation HER2 Antibody-Drug Conjugate (ADC) drug.
Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tabletsDrug
TAS-102 Tablets: Antimetabolite antitumor drug; trifluridine inhibits DNA synthesis by incorporating into tumor cell DNA, while tipiracil increases trifluridine bioavailability by inhibiting its degradation.
Fruquintinib Tablets: Oral small-molecule VEGFR inhibitor; blocks VEGFR 1/2/3 signaling to inhibit tumor angiogenesis, cutting off tumor nutrient and oxygen supply.
Regorafenib Tablets: Multikinase inhibitor; targets VEGFR, PDGFR, Fibroblast Growth Factor Receptor (FGFR), and Raf kinases to inhibit tumor angiogenesis, cell proliferation, and metastasis.
| Study group | Role | What they receive |
|---|---|---|
| TQB2102 Injection | Experimental | TQB2102 Injection, 21days as a treatment cycle, administered on Day 1 of each cycle Receives: Drug: TQB2102 Injection |
| Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets | Experimental | TAS-102 tablets: Oral administration, 35 mg/m² (maximum single dose: 80 mg), twice daily on Days 1-5 and Days 8-12. Each treatment cycle is 4 weeks (Q4W).
Fruquintinib: Oral administration, 5 mg once daily (QD), on Days 1-21 of each cycle. Each treatment cycle is 4 weeks (Q4W).
Regorafenib tablets: Oral administration, 160 mg once daily (QD), on Days 1-21 of each cycle. Each treatment cycle is 4 weeks (Q4W). Receives: Drug: Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) assessed by IRC based on RECIST v1.1
To evaluate the Progression-Free Survival (PFS) assessed by IRC of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Secondary outcomes (11)
Overall Survival (OS)
To evaluate the Overall Survival (OS) of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Objective Response Rate (ORR)
To evaluate the Objective Response Rate (ORR) of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Duration of Response (DOR)
To evaluate the Duration of Response (DOR) of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Disease Control Rate (DCR)
To evaluate the Disease Control Rate (DCR), of TQB2102 Injection compared to investigator-selected chemotherapy in subjects
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Time to Response (TTR) (assessed by both IRC and investigators)
To evaluate the Time to Response (TTR) (assessed by both IRC and investigators), of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Investigator-assessed PFS
To evaluate the investigator-assessed PFS of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Survival rates at 3 months, 6 months, 9 months, and 12 months
To evaluate the Survival rates at 3 months, 6 months, 9 months, and 12 months of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Measured: Baseline, 3, 6, 9, 12 months
Quality of life scores at 3 months, 6 months, 9 months, and 12 months
To evaluate the quality of life scores at 3 months, 6 months, 9 months, and 12 months of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
Higher scores indicate more severe conditions.
Measured: Baseline, 3, 6, 9, 12 months
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months
Pharmacokinetic (PK)-Ctrough
Exploration of the Pharmacokinetic Characteristics of TQB2102 Injection Using Trough Concentrations.
Measured: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 4, Cycle 7, and Cycle 12 (each cycle is 21 days)
Immunogenicity of TQB2102: ADA incidence
Exploration of Anti-Drug Antibody (ADA) Characteristics for TQB2102 Injection.
Measured: Within 1 hour prior to the start of infusion for Cycle 1, 4, 7, and 12, and 90 days after last infusion. (Each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 IHC3+ Advanced Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483684
- Sponsor's protocol ID
- TQB2102-III-03
- Status last verified
- Dec 2025
- First submitted
- 6 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Active-Controlled, Multicenter Phase III Clinical Study to Evaluate Injection TQB2102 Versus Investigator's Choice of Treatment Regimens in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs
- ClinicalTrials.gov ID
- NCT07483684
- Acronym / sponsor ID
- TQB2102-III-03
- Conditions
- HER2 IHC3+ Advanced Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, randomized, open-label, active-controlled, multicenter study designed to evaluate the efficacy and safety of Injection TQB2102 compared with investigator's choice of treatment in subjects with Human Epidermal Growth Factor Receptor 2 (HER2) ImmunoHistoChemistry score 3 (IHC3+) advanced colorectal cancer who have failed prior treatment with oxaliplatin, irinotecan, and fluoropyrimidine-based regimens.
The primary endpoint of this study is progression-free survival (PFS) as assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). Other secondary endpoints include investigator-assessed PFS, objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), safety, and quality of life scores.
Approximately 142 subjects are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the experimental group or the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2102 Injection | Experimental | Drug: TQB2102 InjectionTQB2102 Injection, 21days as a treatment cycle, administered on Day 1 of each cycle |
| Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets | Experimental | Drug: Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tabletsTAS-102 tablets: Oral administration, 35 mg/m² (maximum single dose: 80 mg), twice daily on Days 1-5 and Days 8-12. Each treatment cycle is 4 weeks (Q4W). Fruquintinib: Oral administration, 5 mg once daily (QD), on Days 1-21 of each cycle. Each treatment cycle is 4 weeks (Q4W). Regorafenib tablets: Oral administration, 160 mg once daily (QD), on Days 1-21 of each cycle. Each treatment cycle is 4 weeks (Q4W). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The subject voluntarily participates in this study, signs the informed consent form, and has good compliance.
- Aged 18 to 75 years old (calculated as of the date of signing the informed consent form).
- Subjects with histologically or cytologically confirmed advanced colorectal cancer.
- The subject has confirmed HER2 IHC3+ status in tumor tissue, as determined by the central laboratory designated by the sponsor.
- The subject must provide a sufficient quantity of qualified tumor specimens (fresh or archived samples collected within the past 3 years from primary or metastatic lesions) for central laboratory testing of HER2 status.
Key exclusion criteria (23 listed)
- A history of other malignant tumors within 3 years prior to the first dose, or concurrent malignant tumors at screening. Subjects are eligible for enrollment if they meet one of the following two conditions:
- Presence of diseases that affect intravenous injection or venous blood collection, or factors that impair oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction, etc.).
- Failure of adverse reactions from prior treatments to resolve to ≤ Grade 1 per CTCAE v5.0, with the following exceptions: Grade 2 alopecia, Grade 2 peripheral neurotoxicity, Grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, type 1 diabetes mellitus and hypothyroidism stabilized with hormone replacement therapy, and other toxicities judged by the investigator to pose no safety risks.
- Receipt of major surgical treatment, significant traumatic injury within 4 weeks prior to the first dose; or planned major surgery during the study period (excluding surgeries specified in the protocol); or presence of unhealed wounds or fractures for a prolonged period.
- Clinically significant tumor bleeding or perforation within 1 month prior to the first dose; or any bleeding event ≥ Grade 3 per CTCAE v5.0; or subjects with bleeding or coagulation disorders receiving warfarin, aspirin, or other antiplatelet agents (excluding maintenance doses: aspirin ≤ 100 mg/day, clopidogrel ≤ 75 mg/day); or subjects with a history or signs of bleeding deemed ineligible by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2102 InjectionTQB2102 Injection is a next-generation HER2 Antibody-Drug Conjugate (ADC) drug. | Drug | TQB2102 Injection |
| Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tabletsTAS-102 Tablets: Antimetabolite antitumor drug; trifluridine inhibits DNA synthesis by incorporating into tumor cell DNA, while tipiracil increases trifluridine bioavailability by inhibiting its degradation. Fruquintinib Tablets: Oral small-molecule VEGFR inhibitor; blocks VEGFR 1/2/3 signaling to inhibit tumor angiogenesis, cutting off tumor nutrient and oxygen supply. Regorafenib Tablets: Multikinase inhibitor; targets VEGFR, PDGFR, Fibroblast Growth Factor Receptor (FGFR), and Raf kinases to inhibit tumor angiogenesis, cell proliferation, and metastasis. | Drug | Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets |
Primary outcome
Progression-Free Survival (PFS) assessed by IRC based on RECIST v1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
To evaluate the Progression-Free Survival (PFS) assessed by IRC of TQB2102 Injection compared to investigator-selected chemotherapy in subjects.
11 secondary outcomes
Overall Survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Objective Response Rate (ORR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Duration of Response (DOR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Disease Control Rate (DCR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Time to Response (TTR) (assessed by both IRC and investigators)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Investigator-assessed PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Survival rates at 3 months, 6 months, 9 months, and 12 months
Time frame: Baseline, 3, 6, 9, 12 months
Quality of life scores at 3 months, 6 months, 9 months, and 12 months
Time frame: Baseline, 3, 6, 9, 12 months
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months
Pharmacokinetic (PK)-Ctrough
Time frame: Within 1 hour prior to the start of infusion for Cycle 1, Cycle 4, Cycle 7, and Cycle 12 (each cycle is 21 days)
Immunogenicity of TQB2102: ADA incidence
Time frame: Within 1 hour prior to the start of infusion for Cycle 1, 4, 7, and 12, and 90 days after last infusion. (Each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Related trials for HER2 IHC3+ Advanced Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQB2102 Injection and Trifluridine /Tipiracil (TAS-102) tablets / Fruquintinib / Regorafenib tablets in people with HER2 IHC3+ Advanced Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 48 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruihua Xu, Doctor (020-87343468, xurh@syscc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) assessed by IRC based on RECIST v1.1 (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.