HCC - Hepatocellular CarcinomaPhase 2NCT07776080
Iparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706), Lenvatinib and Radiotherapy in people with HCC - Hepatocellular Carcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study is to learn how well a combination of iparomlimab and tuvonralimab (QL1706), lenvatinib, radiotherapy, and hepatic arterial infusion chemotherapy (HAIC) works and how safe it is for people with hepatocellular carcinoma (HCC) that has grown into the portal vein, forming a portal vein tumor… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- Iparomlimab and Tuvonralimab (QL1706), Lenvatinib and Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 1 Oct 2028
- 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 and ≤75 years at the time of signing informed consent.
- Histologically or clinically confirmed hepatocellular carcinoma (HCC) according to the 2024 Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer.
- Radiologically confirmed portal vein tumor thrombus (PVTT), classified as Cheng type I-IV.
- No prior systemic or local treatment directed at PVTT, including targeted therapy, immunotherapy, or systemic chemotherapy.
- Child-Pugh class A or B with a Child-Pugh score ≤7.
- Considered unsuitable for curative surgery or liver transplantation after multidisciplinary evaluation, but suitable for radiotherapy.
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- Adequate organ function, including: WBC ≥3.0 × 10⁹/L; PLT ≥50 × 10⁹/L; hemoglobin ≥80 g/L; ALT ≤5 × ULN; AST ≤5 × ULN; total bilirubin ≤3 × ULN; albumin ≥28 g/L; and creatinine clearance ≥80 mL/min.
- At least one measurable lesion according to mRECIST.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy >3 months.
- No history of abdominal radiotherapy.
- Women of childbearing potential must use effective contraception beginning at least 1 month before screening and throughout the study until the protocol-specified period after study completion.
- Willing and able to comply with study follow-up until death, study completion, or study termination.
Who cannot join
- ECOG performance status ≥2.
- Child-Pugh score ≥8.
- Severe dysfunction of major organs, including the heart, liver, or kidneys.
- Prior targeted therapy, immunotherapy, radiotherapy, systemic chemotherapy, or other anticancer treatment.
- Known hypersensitivity or allergic reaction to any component of the study treatment.
- History of organ transplantation or autologous/allogeneic stem cell transplantation.
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- Currently receiving chronic systemic immunotherapy or hormonal therapy other than physiologic replacement therapy.
- Any unstable systemic disease, including active infection; uncontrolled severe hypertension; unstable angina; new-onset angina within the previous 3 months; congestive heart failure of NYHA class II or higher; myocardial infarction within the previous 6 months; severe cardiac arrhythmia requiring medication; gastrointestinal bleeding within the previous 1 month; or active bleeding tendency.
- Concurrent other malignancy that has not been cured, except carcinoma in situ at another site.
- Any disease, metabolic disorder, physical examination finding, or laboratory abnormality that, in the investigator's judgment, suggests a contraindication to the study treatment or a high risk of treatment-related complications.
- Evidence of acute or active hepatitis B or hepatitis C infection, including HBV-DNA >2,000 IU/mL or HCV-RNA >1,000 copies/mL.
- Pregnancy or breastfeeding.
- Any other unfavorable medical or psychiatric condition that, in the investigator's judgment, may affect protocol compliance or evaluation of study endpoints and makes the participant unsuitable for the study.
- Lack of legal capacity or limited legal capacity.
- Other contraindications to radiotherapy or targeted/immunotherapy.
- Any participant considered unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Wuhan, Hubei, 430022
Jun Xue, Doctor, 027-83262682, junxue_xh@hust.edu.cn
About this study
Official title: A Clinical Study of Iparomlimab and Tuvonralimab Combined With Lenvatinib, Radiotherapy, and Hepatic Arterial Infusion Chemotherapy as First-Line Treatment for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
The purpose of this study is to learn how well a combination of iparomlimab and tuvonralimab (QL1706), lenvatinib, radiotherapy, and hepatic arterial infusion chemotherapy (HAIC) works and how safe it is for people with hepatocellular carcinoma (HCC) that has grown into the portal vein, forming a portal vein tumor thrombus (PVTT).
Participants will receive iparomlimab and tuvonralimab together with lenvatinib, radiotherapy directed at the portal vein tumor thrombus, and HAIC, which delivers chemotherapy directly through the hepatic artery. Researchers will evaluate how long the cancer remains controlled without getting worse, how much the tumors shrink, how long participants survive, and whether the treatment makes surgery possible for some participants. Treatment-related side effects will also be assessed.
The study will also explore whether features in tumor tissue and blood are associated with treatment response and may help identify patients who are more likely to benefit from this treatment strategy.
Read the detailed description
This is a prospective, single-center, single-arm Phase II study designed to evaluate the efficacy and safety of a multimodal first-line treatment strategy consisting of iparomlimab and tuvonralimab (QL1706), lenvatinib, radiotherapy, and hepatic arterial infusion chemotherapy (HAIC) in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT). A total of 35 participants are planned to be enrolled.
Treatment will be administered according to the following sequence. Iparomlimab and tuvonralimab (QL1706) will be administered intravenously at a dose of 7.5 mg/kg on Day 1 of each 3-week cycle, with each infusion given over 30-60 minutes. Lenvatinib will be administered orally once daily at 8 mg for participants weighing <60 kg and 12 mg for those weighing ≥60 kg.
PVTT-directed external beam radiotherapy will be initiated within 7 days after the first administration of QL1706. The radiation target will include the PVTT. Gross tumor volume will be delineated based on the venous or delayed phase of contrast-enhanced imaging. A planning target volume margin of approximately 5-15 mm will be added according to the protocol. Stereotactic body radiotherapy will be delivered at a total dose of 18-40 Gy, with a dose of 3-6 Gy per fraction.
HAIC will be initiated in combination with the second cycle of QL1706. Lenvatinib will be withheld for 3 days before HAIC and for 7 days after HAIC. The interruption period may be extended at the investigator's discretion according to the participant's clinical condition and laboratory findings. HAIC will be performed using a FOLFOX-based regimen through a catheter selectively placed in the main tumor-feeding hepatic artery. Oxaliplatin will be administered at 85 mg/m² by hepatic arterial infusion over 3 hours, followed by leucovorin calcium at 200 mg/m² over 3-5 hours. Fluorouracil will then be administered at 400 mg/m² by hepatic arterial injection, followed by 2400 mg/m² as a continuous hepatic arterial infusion over 46 hours. HAIC will be repeated every 3 weeks for up to 4 cycles, with the number of cycles adjusted according to the participant's clinical condition.
QL1706 and lenvatinib will be continued for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for treatment discontinuation. Tumor response will be assessed every 2 treatment cycles, corresponding to approximately every 6 weeks, according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Participants who achieve sufficient tumor regression will be reviewed by a multidisciplinary team, and those considered suitable for curative resection may undergo conversion surgery.
The primary objective of the study is to evaluate progression-free survival. Secondary assessments include objective response rate, disease control rate, duration of response, overall survival, conversion-to-surgery rate, pathological complete response in participants undergoing surgery, and treatment safety.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- Iparomlimab and Tuvonralimab (QL1706), Lenvatinib, Radiotherapy, hepatic arterial infusion chemotherapy (HAIC)
- Keywords
- Hepatocellular Carcinoma, Portal Vein Tumor Thrombus, Lenvatinib, Iparomlimab and Tuvonralimab, Radiotherapy, Hepatic Arterial Infusion Chemotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab (QL1706)Drug
Iparomlimab and tuvonralimab (QL1706) will be administered intravenously at 7.5 mg/kg on Day 1 of each 3-week cycle. Each infusion will be administered over 30-60 minutes. Treatment will continue for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation.
LenvatinibDrug
Lenvatinib will be administered orally once daily at 8 mg for participants weighing <60 kg and 12 mg for participants weighing ≥60 kg. During HAIC treatment, lenvatinib will be withheld for 3 days before HAIC and for 7 days after HAIC. The interruption period may be extended at the investigator's discretion based on the participant's clinical condition and laboratory findings. Lenvatinib will continue for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation.
RadiotherapyRadiation
External beam radiotherapy directed at the portal vein tumor thrombus (PVTT) will be initiated within 7 days after the first administration of QL1706. The radiation target will include the PVTT. Gross tumor volume will be delineated based on the venous or delayed phase of contrast-enhanced imaging, and a planning target volume margin of approximately 5-15 mm will be applied according to the protocol. SBRT will be delivered at a total dose of 18-40 Gy with 3-6 Gy per fraction.
hepatic arterial infusion chemotherapy (HAIC)Procedure or surgery
HAIC will be initiated during Cycle 2 of systemic therapy. Using a modified Seldinger technique, a catheter will be selectively placed in the main tumor-feeding hepatic artery for administration of FOLFOX chemotherapy. HAIC will be repeated every 3 weeks for up to 4 cycles, with the number of cycles adjusted according to the participant's clinical condition
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants will receive iparomlimab and tuvonralimab (QL1706) at 7.5 mg/kg intravenously on Day 1 every 3 weeks, together with oral lenvatinib once daily (8 mg for body weight <60 kg and 12 mg for body weight ≥60 kg). PVTT-directed radiotherapy will be initiated within 7 days after the first QL1706 administration. HAIC with a FOLFOX regimen will be added from Cycle 2 and repeated every 3 weeks for up to 4 cycles. Lenvatinib will be withheld for 3 days before and 7 days after each HAIC procedure. QL1706 and lenvatinib will continue for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation. Receives: Drug: Iparomlimab and Tuvonralimab (QL1706); Drug: Lenvatinib; Radiation: Radiotherapy; Procedure: hepatic arterial infusion chemotherapy (HAIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the first administration of study treatment to the first documented radiographic disease progression, as assessed by the investigator according to mRECIST, or death from any cause, whichever occurs first.
Measured: From first administration of study treatment to radiographic disease progression or death from any cause, whichever occurs first, up to 24 months
Secondary outcomes (3)
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR), as assessed by the investigator according to mRECIST.
Measured: From first administration of study treatment to disease progression or the last tumor assessment, up to 24 months
Overall Survival (OS)
Overall survival is defined as the time from the first administration of study treatment to death from any cause.
Measured: From first administration of study treatment to death from any cause, up to 24 months
Incidence and Severity of Adverse Events
The incidence and severity of adverse events will be assessed and graded according to NCI CTCAE version 5.0.
Measured: From informed consent through 30 days after the last administration of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776080
- Sponsor's protocol ID
- UHCC-A1c
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Iparomlimab and Tuvonralimab Combined With Lenvatinib, Radiotherapy, and Hepatic Arterial Infusion Chemotherapy as First-Line Treatment for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
- ClinicalTrials.gov ID
- NCT07776080
- Acronym / sponsor ID
- UHCC-A1c
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Portal Vein Tumor Thrombus, Lenvatinib, Iparomlimab and Tuvonralimab, Radiotherapy, Hepatic Arterial Infusion Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 20 Aug 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.
The purpose of this study is to learn how well a combination of iparomlimab and tuvonralimab (QL1706), lenvatinib, radiotherapy, and hepatic arterial infusion chemotherapy (HAIC) works and how safe it is for people with hepatocellular carcinoma (HCC) that has grown into the portal vein, forming a portal vein tumor thrombus (PVTT).
Participants will receive iparomlimab and tuvonralimab together with lenvatinib, radiotherapy directed at the portal vein tumor thrombus, and HAIC, which delivers chemotherapy directly through the hepatic artery. Researchers will evaluate how long the cancer remains controlled without getting worse, how much the tumors shrink, how long participants survive, and whether the treatment makes surgery possible for some participants. Treatment-related side effects will also be assessed.
The study will also explore whether features in tumor tissue and blood are associated with treatment response and may help identify patients who are more likely to benefit from this treatment strategy.
Detailed description
This is a prospective, single-center, single-arm Phase II study designed to evaluate the efficacy and safety of a multimodal first-line treatment strategy consisting of iparomlimab and tuvonralimab (QL1706), lenvatinib, radiotherapy, and hepatic arterial infusion chemotherapy (HAIC) in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT). A total of 35 participants are planned to be enrolled.
Treatment will be administered according to the following sequence. Iparomlimab and tuvonralimab (QL1706) will be administered intravenously at a dose of 7.5 mg/kg on Day 1 of each 3-week cycle, with each infusion given over 30-60 minutes. Lenvatinib will be administered orally once daily at 8 mg for participants weighing <60 kg and 12 mg for those weighing ≥60 kg.
PVTT-directed external beam radiotherapy will be initiated within 7 days after the first administration of QL1706. The radiation target will include the PVTT. Gross tumor volume will be delineated based on the venous or delayed phase of contrast-enhanced imaging. A planning target volume margin of approximately 5-15 mm will be added according to the protocol. Stereotactic body radiotherapy will be delivered at a total dose of 18-40 Gy, with a dose of 3-6 Gy per fraction.
HAIC will be initiated in combination with the second cycle of QL1706. Lenvatinib will be withheld for 3 days before HAIC and for 7 days after HAIC. The interruption period may be extended at the investigator's discretion according to the participant's clinical condition and laboratory findings. HAIC will be performed using a FOLFOX-based regimen through a catheter selectively placed in the main tumor-feeding hepatic artery. Oxaliplatin will be administered at 85 mg/m² by hepatic arterial infusion over 3 hours, followed by leucovorin calcium at 200 mg/m² over 3-5 hours. Fluorouracil will then be administered at 400 mg/m² by hepatic arterial injection, followed by 2400 mg/m² as a continuous hepatic arterial infusion over 46 hours. HAIC will be repeated every 3 weeks for up to 4 cycles, with the number of cycles adjusted according to the participant's clinical condition.
QL1706 and lenvatinib will be continued for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for treatment discontinuation. Tumor response will be assessed every 2 treatment cycles, corresponding to approximately every 6 weeks, according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Participants who achieve sufficient tumor regression will be reviewed by a multidisciplinary team, and those considered suitable for curative resection may undergo conversion surgery.
The primary objective of the study is to evaluate progression-free survival. Secondary assessments include objective response rate, disease control rate, duration of response, overall survival, conversion-to-surgery rate, pathological complete response in participants undergoing surgery, and treatment safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Iparomlimab and Tuvonralimab (QL1706), Drug: Lenvatinib, Radiation: Radiotherapy, Procedure: hepatic arterial infusion chemotherapy (HAIC)Participants will receive iparomlimab and tuvonralimab (QL1706) at 7.5 mg/kg intravenously on Day 1 every 3 weeks, together with oral lenvatinib once daily (8 mg for body weight <60 kg and 12 mg for body weight ≥60 kg). PVTT-directed radiotherapy will be initiated within 7 days after the first QL1706 administration. HAIC with a FOLFOX regimen will be added from Cycle 2 and repeated every 3 weeks for up to 4 cycles. Lenvatinib will be withheld for 3 days before and 7 days after each HAIC procedure. QL1706 and lenvatinib will continue for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 and ≤75 years at the time of signing informed consent.
- Histologically or clinically confirmed hepatocellular carcinoma (HCC) according to the 2024 Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer.
- Radiologically confirmed portal vein tumor thrombus (PVTT), classified as Cheng type I-IV.
- No prior systemic or local treatment directed at PVTT, including targeted therapy, immunotherapy, or systemic chemotherapy.
- Child-Pugh class A or B with a Child-Pugh score ≤7.
Key exclusion criteria (16 listed)
- ECOG performance status ≥2.
- Child-Pugh score ≥8.
- Severe dysfunction of major organs, including the heart, liver, or kidneys.
- Prior targeted therapy, immunotherapy, radiotherapy, systemic chemotherapy, or other anticancer treatment.
- Known hypersensitivity or allergic reaction to any component of the study treatment.
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 |
|---|---|---|
| Iparomlimab and Tuvonralimab (QL1706)Iparomlimab and tuvonralimab (QL1706) will be administered intravenously at 7.5 mg/kg on Day 1 of each 3-week cycle. Each infusion will be administered over 30-60 minutes. Treatment will continue for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation. | Drug | Treatment group |
| LenvatinibLenvatinib will be administered orally once daily at 8 mg for participants weighing <60 kg and 12 mg for participants weighing ≥60 kg. During HAIC treatment, lenvatinib will be withheld for 3 days before HAIC and for 7 days after HAIC. The interruption period may be extended at the investigator's discretion based on the participant's clinical condition and laboratory findings. Lenvatinib will continue for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation. | Drug | Treatment group |
| RadiotherapyExternal beam radiotherapy directed at the portal vein tumor thrombus (PVTT) will be initiated within 7 days after the first administration of QL1706. The radiation target will include the PVTT. Gross tumor volume will be delineated based on the venous or delayed phase of contrast-enhanced imaging, and a planning target volume margin of approximately 5-15 mm will be applied according to the protocol. SBRT will be delivered at a total dose of 18-40 Gy with 3-6 Gy per fraction. | Radiation | Treatment group |
| hepatic arterial infusion chemotherapy (HAIC)HAIC will be initiated during Cycle 2 of systemic therapy. Using a modified Seldinger technique, a catheter will be selectively placed in the main tumor-feeding hepatic artery for administration of FOLFOX chemotherapy. HAIC will be repeated every 3 weeks for up to 4 cycles, with the number of cycles adjusted according to the participant's clinical condition | Procedure or surgery | Treatment group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From first administration of study treatment to radiographic disease progression or death from any cause, whichever occurs first, up to 24 months
Progression-free survival is defined as the time from the first administration of study treatment to the first documented radiographic disease progression, as assessed by the investigator according to mRECIST, or death from any cause, whichever occurs first.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: From first administration of study treatment to disease progression or the last tumor assessment, up to 24 months
Overall Survival (OS)
Time frame: From first administration of study treatment to death from any cause, up to 24 months
Incidence and Severity of Adverse Events
Time frame: From informed consent through 30 days after the last administration of study treatment
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 15 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706), Lenvatinib and Radiotherapy in people with HCC - Hepatocellular Carcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site 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 13 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jun Xue, Doctor (027-83262682, junxue_xh@hust.edu.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) (time frame: From first administration of study treatment to radiographic disease progression or death from any cause, whichever occurs first, up to 24 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 15 Sep 2026.