Neuroendocrine CancerPhase 2NCT07712094
AK112 Combination Therapy as First Line Treatment for Metastatic Digestive System Neuroendocrine Cancer
A Phase 2 study testing AK112, Irinotecan and Cisplatin in people with Neuroendocrine Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 8 sites in China.
Trial summary
This study is a single prospective, parallel, double-cohort, multicenter phase II clinical trial, aiming to evaluate the efficacy and safety of ivonescimab (AK112) combined with IP chemotherapy ± TACE in the first-line treatment of metastatic digestive system neuroendocrine cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuroendocrine Cancer
- What is being tested?
- AK112, Irinotecan and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 8 sitesChina
- Study dates
- 1 Aug 2026to 31 Aug 2029
- Phase
- Phase 2
- 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
- Age: 18 - 75 years old;
- Metastatic digestive system neuroendocrine carcinoma (NEC) confirmed by tissue or cytological examination;
- For cohort 2 only: Liver metastasis, suitable for TACE;
- No previous systemic treatment; For patients who received adjuvant therapy, disease recurrence and metastasis more than 6 months after the last treatment can be regarded as first-line treatment;
- Clear measurable lesions meeting the requirements of RECIST (1.1); If the lesion that received previous local treatment (radiation, ablation, vascular intervention, etc.) is the only lesion, there must be clear imaging evidence of disease progression for this lesion;
- ECOG score of 0 or 1;
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- Expected survival ≥ 12 weeks;
- Basic normal functions of major organs and bone marrow;
- Male or female patients with reproductive capacity voluntarily use effective contraceptive methods during the study period and within 6 months after the last study medication, such as double barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered to have reproductive capacity, unless the female patient has naturally menopause, artificial menopause or sterilization (such as hysterectomy, bilateral ovary removal or radiotherapy of the ovaries, etc.).
- Have fully understood this study, voluntarily participated, and signed the informed consent form.
Who cannot join
- Within the past 5 years, have been diagnosed with other malignant tumors (excluding carcinoma in situ, basal cell carcinoma, etc.);
- Known to be allergic to any component of any study drug; have a history of severe hypersensitivity reaction to other monoclonal antibodies;
- Within 4 weeks before enrollment, have received approved or investigational systemic anti-tumor treatment, including: photodynamic therapy, chemotherapy, radical radiotherapy, ablation, local radiotherapy (allowing for palliative radiotherapy for bone metastases at least 2 weeks before the study drug treatment), biological immunotherapy, targeted therapy, etc.;
- Within 4 weeks before enrollment, have participated in other domestic clinical trials of drugs that have not been approved or are not yet on the market and have received corresponding trial drug treatment;
- Within 4 weeks before enrollment, have received any surgery or invasive treatment or operation (except for intravenous catheterization, puncture drainage, etc.);
- The patient currently has active ulcers in the stomach and duodenum, ulcerative colitis and other digestive tract diseases or active bleeding from the unresected tumor, or conditions that the investigator deems may cause gastrointestinal bleeding or perforation;
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- Within 3 months before enrollment, have obvious evidence or history of bleeding (more than 30 mL of bleeding within 3 months, hematemesis, black stool, bloody stool), hemoptysis (more than 5 mL of fresh blood within 4 weeks), or have had a thromboembolic event within 12 months (including stroke events and/or transient ischemic attacks);
- Have significant clinical cardiovascular diseases, including but not limited to acute myocardial infarction within 6 months before enrollment, severe/unstable angina pectoris or coronary artery bypass surgery; New York Heart Association (NYHA) class > 2 for congestive heart failure; Drug treatment for ventricular arrhythmias; Electrocardiogram (ECG) showing QTc interval ≥ 480 milliseconds;
- Unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis or meningitis metastasis;
- Have third space fluid that cannot be controlled by drainage methods (such as large amounts of ascites, pleural effusion, pericardial effusion, etc.), and the subjects need to control the third space fluid through drainage within 14 days before administration;
- Active or uncontrolled severe infection (≥ CTCAE grade 2 infection);
- Known human immunodeficiency virus (HIV) infection; Known significant liver disease history, including viral hepatitis [must exclude active HBV infection if the HBV DNA is positive (> 1×10^4 copies/mL or > 2000 IU/ml); known hepatitis C infection (HCV) and HCV RNA positive (> 1×10^3 copies/mL), or other hepatitis, liver cirrhosis];
- Known mental illness, drug abuse, alcoholism or drug addiction history.
- Pregnant or lactating women.
- Have any disease, treatment, laboratory test abnormalities in the past or currently, which may confuse the research results, affect the full participation of the subjects in the research, or the participation in the research may not be in the best interests of the subjects.
- Local or systemic diseases not caused by malignant tumors, or secondary diseases or symptoms of tumors, which may lead to higher medical risks and/or uncertainty in survival period evaluation, such as tumor leukemia reaction (white blood cell count > 20×109/L), cachexia manifestations (such as weight loss of more than 10% within 3 months before screening), etc.
- Patients judged by the investigator to be unsuitable to participate in this study.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
Baotou Cancer Hospital
Baotou, Inner Mongolia
Yunqi Hua, 86+13015056119, hyqyfr@126.com
Shanxi Bethune Hospital
Taiyuan, Shanxi
Yarong Guo, 86+13453410624, gyr5258@126.com
Tianjin First Central Hospital
Tianjin
Bing Ang, 86+16622108047, able12ab@163.com
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Rui Liu, Dr., 86+022-23340123, liurui9003@163.com
Tianjin Medical University General Hospital
Tianjin
Qiong Qin, 86+13512203140, qinqiong_@126.com
Tianjin People's Hospital
Tianjin
Hao Yan, 86+132 0760 3727, sarahhao99@sina.cn
Tianjin Third Central Hospital
Tianjin
Hongsheng Guo, 86+18522107098, uc999888@163.com
The First People's Hospital of Horqin District, Tongliao City
Tongliao, Inner Mongolia
Ning Chen, 86+13948556479, 1599108551@qq.com
About this study
Official title: A Prospective, Parallel, Double-cohort, Multicenter Phase II Clinical Study of Ivonescimab (AK112) Combined With IP Chemotherapy ± TACE for First-line Treatment of Metastatic Digestive System Neuroendocrine Cancer
This study is a single prospective, parallel, double-cohort, multicenter phase II clinical trial, aiming to evaluate the efficacy and safety of ivonescimab (AK112) combined with IP chemotherapy ± TACE in the first-line treatment of metastatic digestive system neuroendocrine cancer.
- Conditions
- Neuroendocrine Cancer
- Being tested
- AK112, Irinotecan, Cisplatin, TACE
- Medical subject headings
- Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112Drug
Combination treatment period (4-6 cycles):
AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks
Maintenance treatment period:
AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks
IrinotecanDrug
Combination treatment period (4-6 cycles):
Irinotecan: 65 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks
CisplatinDrug
Combination treatment period (4-6 cycles):
Cisplatin: 30 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks
TACEProcedure or surgery
Combination treatment period:
TACE with epirubicin, 30-40 mg, every 3 weeks or every 6 weeks. The total treatment cycle is determined as needed.
| Study group | Role | What they receive |
|---|---|---|
| NEC | Experimental | Not described Receives: Drug: AK112; Drug: Irinotecan; Drug: Cisplatin |
| NEC with liver metastases | Experimental | Not described Receives: Drug: AK112; Drug: Irinotecan; Drug: Cisplatin; Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
PFS is defined as the time from date of treatment start to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1
Measured: Up to 2 years
Secondary outcomes (5)
objective response rate (ORR)
Proportion of participants with complete response (CR) or partial response (PR), as assessed by RECIST version 1.1
Measured: Up to 2 years
disease control rate (DCR)
Proportion of subjects with CR,PR, or SD based on RECIST Version 1.1.
Measured: Up to 2 years
duration of response (DOR)
Time from the first documentation of objective response to the first documented disease progression as assessed by RECIST version 1.1 or death due to any cause, whichever occurs first
Measured: Up to 2 years
overall survival (OS)
Time from the date of treatment start to death due to any cause
Measured: Up to 2 years
The number of subjects experiencing adverse events (AEs)
Measured: From the time of treatment start through 90 days following termination of treatment with investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion27 Feb 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was a parallel double cohort design. Cohort 1 included patients with metastatic digestive system neuroendocrine cancer who had not received systemic treatment. They received AK112 combined with IP chemotherapy, followed by maintenance with AK112 monotherapy. Cohort 2 included patients with liver metastatic digestive system neuroendocrine cancer who had not received systemic treatment. They received AK112 combined with IP chemotherapy, along with TACE, and then maintained with AK112 monotherapy. The treatment continued until the subjects experienced disease progression, intolerable toxicity, the decision of the investigator, the subject withdrawing informed consent, death, or other reasons stipulated in the protocol.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712094
- Sponsor's protocol ID
- AK112-IIT-C-N-0010
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Parallel, Double-cohort, Multicenter Phase II Clinical Study of Ivonescimab (AK112) Combined With IP Chemotherapy ± TACE for First-line Treatment of Metastatic Digestive System Neuroendocrine Cancer
- ClinicalTrials.gov ID
- NCT07712094
- Acronym / sponsor ID
- AK112-IIT-C-N-0010
- Conditions
- Neuroendocrine Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 27 Feb 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 17 Jul 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 study is a single prospective, parallel, double-cohort, multicenter phase II clinical trial, aiming to evaluate the efficacy and safety of ivonescimab (AK112) combined with IP chemotherapy ± TACE in the first-line treatment of metastatic digestive system neuroendocrine cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was a parallel double cohort design. Cohort 1 included patients with metastatic digestive system neuroendocrine cancer who had not received systemic treatment. They received AK112 combined with IP chemotherapy, followed by maintenance with AK112 monotherapy. Cohort 2 included patients with liver metastatic digestive system neuroendocrine cancer who had not received systemic treatment. They received AK112 combined with IP chemotherapy, along with TACE, and then maintained with AK112 monotherapy. The treatment continued until the subjects experienced disease progression, intolerable toxicity, the decision of the investigator, the subject withdrawing informed consent, death, or other reasons stipulated in the protocol.
| Arm | Type | Receives |
|---|---|---|
| NEC | Experimental | Drug: AK112, Drug: Irinotecan, Drug: Cisplatin |
| NEC with liver metastases | Experimental | Drug: AK112, Drug: Irinotecan, Drug: Cisplatin, Procedure: TACE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18 - 75 years old;
- Metastatic digestive system neuroendocrine carcinoma (NEC) confirmed by tissue or cytological examination;
- For cohort 2 only: Liver metastasis, suitable for TACE;
- No previous systemic treatment; For patients who received adjuvant therapy, disease recurrence and metastasis more than 6 months after the last treatment can be regarded as first-line treatment;
- Clear measurable lesions meeting the requirements of RECIST (1.1); If the lesion that received previous local treatment (radiation, ablation, vascular intervention, etc.) is the only lesion, there must be clear imaging evidence of disease progression for this lesion;
Key exclusion criteria (17 listed)
- Within the past 5 years, have been diagnosed with other malignant tumors (excluding carcinoma in situ, basal cell carcinoma, etc.);
- Known to be allergic to any component of any study drug; have a history of severe hypersensitivity reaction to other monoclonal antibodies;
- Within 4 weeks before enrollment, have received approved or investigational systemic anti-tumor treatment, including: photodynamic therapy, chemotherapy, radical radiotherapy, ablation, local radiotherapy (allowing for palliative radiotherapy for bone metastases at least 2 weeks before the study drug treatment), biological immunotherapy, targeted therapy, etc.;
- Within 4 weeks before enrollment, have participated in other domestic clinical trials of drugs that have not been approved or are not yet on the market and have received corresponding trial drug treatment;
- Within 4 weeks before enrollment, have received any surgery or invasive treatment or operation (except for intravenous catheterization, puncture drainage, etc.);
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 |
|---|---|---|
| AK112Combination treatment period (4-6 cycles): AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks Maintenance treatment period: AK112: 20mg/kg, intravenous infusion, administered on day 1, repeated every 3 weeks | Drug | NEC, NEC with liver metastases |
| IrinotecanCombination treatment period (4-6 cycles): Irinotecan: 65 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks | Drug | NEC, NEC with liver metastases |
| CisplatinCombination treatment period (4-6 cycles): Cisplatin: 30 mg/m2, intravenous infusion, administered on days 1 and 8, repeated every 3 weeks | Drug | NEC, NEC with liver metastases |
| TACECombination treatment period: TACE with epirubicin, 30-40 mg, every 3 weeks or every 6 weeks. The total treatment cycle is determined as needed. | Procedure or surgery | NEC with liver metastases |
Primary outcome
progression-free survival (PFS)
Time frame: Up to 2 years
PFS is defined as the time from date of treatment start to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1
5 secondary outcomes
objective response rate (ORR)
Time frame: Up to 2 years
disease control rate (DCR)
Time frame: Up to 2 years
duration of response (DOR)
Time frame: Up to 2 years
overall survival (OS)
Time frame: Up to 2 years
The number of subjects experiencing adverse events (AEs)
Time frame: From the time of treatment start through 90 days following termination of treatment with investigational product
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 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK112, Irinotecan and Cisplatin in people with Neuroendocrine Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 8 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 10 inclusion and 17 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Rui Liu, Dr. (86+022-23340123, liurui9003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: Up to 2 years). 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 17 Jul 2026.