Pancreatic NeoplasmsPhase 2NCT06767813
Clinical Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy in the First-line Treatment of Metastatic Pancreatic Neoplasms
A Phase 2 study testing TQB2868 injection, Gemcitabine injection and Albumin paclitaxel injection in people with Pancreatic Neoplasms, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 7 sites in China.
Trial summary
To evaluate the efficacy and safety of TQB2868 injection combined with anlotinib capsule and chemotherapy in treated patients with Pancreatic Neoplasms Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- TQB2868 injection, Gemcitabine injection and Albumin paclitaxel injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesChina
- Study dates
- 19 Mar 2024to Nov 2026
- 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
- Subjects must voluntarily participate in the study and sign the informed consent form.
- Aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.
- Diagnosed with pancreatic ductal adenocarcinoma through histological or cytological confirmation.
- Have at least one evaluable metastatic lesion according to RECIST 1.1 criteria;
- No prior systemic anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy). Patients who experience disease progression more than 6 months after completing neoadjuvant or adjuvant therapy are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of more than 3 months.
- Normal major organ function.
- Patients must use reliable contraception during the study period and for 6 months after the end of the study period; Female participants must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.
Who cannot join
- Subjects with a history of or concurrent diagnosis of other malignant tumors within the past 5 years.
- Unresolved toxicities from prior treatments exceeding Grade 1 according to Common Terminology Criteria (CTC) AE criteria, excluding alopecia.
- Major surgical procedures, significant traumatic injuries, or unhealed wounds or fractures within 28 days prior to the first dose.
- Any bleeding or hemorrhagic event of ≥ Grade 3 according to CTC AE criteria within 4 weeks prior to the first dose.
- Arterial or venous thrombotic events within 6 months prior to the first dose.
- Active gastric or duodenal ulcers, perforations, persistent positive fecal occult blood tests, ulcerative colitis, or other gastrointestinal bleeding conditions within 6 months prior to the first dose; or other bleeding conditions as assessed by the investigator.
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- Hepatitis B virus (HBV)-infected patients unable to adhere to consistent antiviral therapy, or Hepatitis C virus (HCV)-infected patients (positive for HCV Ab or HCV RNA) deemed unstable by the investigator or requiring continued antiviral therapy without consistent adherence.
- History of substance abuse involving psychotropic drugs that cannot be discontinued or presence of psychiatric disorders.
- Symptomatic interstitial lung disease or conditions likely to cause drug-induced lung toxicity or related pneumonitis.
- Presence of any severe and/or uncontrolled diseases.
- Histological or cytological confirmation of other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, or pancreatoblastoma.
- Tumors confirmed via imaging (CT or MRI) to have invaded major blood vessels, with the investigator deeming a high likelihood of fatal hemorrhage during the study.
- Tumors confirmed via imaging (CT or MRI) to have invaded the gastrointestinal tract, with a high risk of bleeding based on endoscopy and investigator assessment.
- Known central nervous system metastases and/or carcinomatous meningitis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage, as assessed by the investigator.
- History of severe allergic reactions to biologic agents or known hypersensitivity to any component of TQB2868 injection.
- Chronic treatment with systemic corticosteroids or other immunosuppressive agents within 28 days prior to the first dose, and continued use of such medications within 2 weeks after the first dose.
- Receipt of live attenuated vaccines within 28 days prior to the first dose or planned administration of live attenuated vaccines during the study.
- Systemic therapy required within 2 years prior to the first dose for any condition. Alternative therapies are not considered systemic therapy.
- Participation in other clinical trials involving anti-tumor drugs within 28 days prior to the first dose.
- Any comorbidities or conditions deemed by the investigator to pose severe risks to the subject's safety or the completion of the study, or any other reasons rendering the subject unsuitable for enrollment.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000
Kuirong Jiang, Doctor, 15312995688, jiangkuirong@163.com
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Juan Du, Doctor, 13951826526, dujuanglyy@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xianjun Yu, Doctor, 021-64175590, yuxianjun@fudanpci.org
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Wei Li, Doctor, 15895401045, liwei10@suda.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Gang Chen, Doctor, 13616619566, cg_2188@126.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Xiaobing Chen, Doctor, 13937100233, 2290773710@qq.com
- Not yet recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450039
Jian Wang, Doctor, 13663000871, wj68happy@hotmail.com
About this study
Official title: Multi-cohort, Open, Phase II Clinical Study of TQB2868 Injection Combined With Arotinib Capsule and Chemotherapy in the First-line Treatment of Pancreatic Neoplasms
To evaluate the efficacy and safety of TQB2868 injection combined with anlotinib capsule and chemotherapy in treated patients with Pancreatic Neoplasms
- Conditions
- Pancreatic Neoplasms
- Being tested
- TQB2868 injection, Gemcitabine injection, Albumin paclitaxel injection, Anlotinib capsules
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2868 injectionDrug
TQB2868 injection is an anti-PD 1/growth factor (GF)-β Receptor Type II (TGF-βRII) bifunctional fusion protein.
Gemcitabine injectionDrug
Gemcitabine injection
Albumin paclitaxel injectionDrug
Albumin paclitaxel injection
Anlotinib capsulesDrug
Anlotinib capsules
| Study group | Role | What they receive |
|---|---|---|
| TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules | Experimental | Treatment period:
TQB2868 injection combined with Gemcitabine injection and Albumin paclitaxel injection, 28 days as a treatment cycle.
Oral administration of Anlotinib capsules tablets once a day, for 2 weeks followed by a 1 week untreated recovery phase.
Maintenance period:
TQB2868 injection combined with Gemcitabine injection, 21 days as a treatment cycle.
Oral administration of Anlotinib capsules tablets once a day, for 2 weeks followed by a 1 week untreated recovery phase. Receives: Drug: TQB2868 injection; Drug: Gemcitabine injection; Drug: Albumin paclitaxel injection; Drug: Anlotinib capsules |
| TQB2868 injection+Gemcitabine injection +Albumin paclitaxel injection | Experimental | Treatment period TQB2868 injection combined with Gemcitabine injection and Albumin paclitaxel injection, 28 days as a treatment cycle.
Maintenance period TQB2868 injection combined with Gemcitabine injection, 21 days as a treatment cycle. Receives: Drug: TQB2868 injection; Drug: Gemcitabine injection; Drug: Albumin paclitaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The time between the start of treatment and tumorigenesis (in any aspect) progression or death (due to any cause).
The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days).
Measured: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Secondary outcomes (12)
Objective Response Rate (ORR)
The proportion of patients whose tumors have shrunk to a prespecified value and are able to maintain the minimum time limit is the sum of the proportion of complete and partial responses.
Measured: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Overall survival (OS)
Time from the start of treatment to death (due to any cause).
Measured: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Duration of Response (DOR)
The period between the first diagnosis of CR or PR and the discovery of progressive disease (PD).
Measured: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Disease Control Rate (DCR)
The percentage of cases with remission (PR+CR) and stable lesion (SD) after treatment accounted for the number of evaluable cases.
Measured: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Incidence and severity of adverse events (AEs)
The occurrence of all adverse events.
Measured: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Peak concentration (Cmax)
Maximum plasma drug concentration.
Measured: Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
Transforming growth factor-beta (TGF-β)
The relationship between TGF - β content in plasma and anti-tumor efficacy.
Measured: Before first dose, 30 minutes after the first dose, pre-dose at Cycle 2 Day 1, pre-dose at the first efficacy assessment, pre-dose at the time of remission at the first efficacy evaluation, and at the time of progression, each cycle is 28 days.
Incidence of immunogenicity (ADA)
Incidence of immunogenicity (ADA).
Measured: Cycle1, 2, 4, 8: Before injection. 30 and 90 days after the last dose
Time to maximum blood concentration (Tmax)
Time to maximum blood concentration.
Measured: Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
Area under the time-concentration curve (AUC0-t）
Area under the time-concentration curve, 0-t hours after administration.
Measured: Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
The area under the time-concentration curve ranges from 0 to infinity after administration (AUC0-∞)
The area under the time-concentration curve ranges from 0 to infinity after administration (AUC0-∞).
Measured: Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
Plasma drug half-life (T1/2)
Plasma drug half-life
Measured: Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start19 Mar 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767813
- Sponsor's protocol ID
- TQB2868-ALTN-II-01
- Status last verified
- Aug 2025
- First submitted
- 6 Jan 2025
- Last updated
- 19 Sep 2025
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-cohort, Open, Phase II Clinical Study of TQB2868 Injection Combined With Arotinib Capsule and Chemotherapy in the First-line Treatment of Pancreatic Neoplasms
- ClinicalTrials.gov ID
- NCT06767813
- Acronym / sponsor ID
- TQB2868-ALTN-II-01
- Conditions
- Pancreatic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Jan 2025 (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.
To evaluate the efficacy and safety of TQB2868 injection combined with anlotinib capsule and chemotherapy in treated patients with Pancreatic Neoplasms
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules | Experimental | Drug: TQB2868 injection, Drug: Gemcitabine injection, Drug: Albumin paclitaxel injection, Drug: Anlotinib capsulesTreatment period: TQB2868 injection combined with Gemcitabine injection and Albumin paclitaxel injection, 28 days as a treatment cycle. Oral administration of Anlotinib capsules tablets once a day, for 2 weeks followed by a 1 week untreated recovery phase. Maintenance period: TQB2868 injection combined with Gemcitabine injection, 21 days as a treatment cycle. Oral administration of Anlotinib capsules tablets once a day, for 2 weeks followed by a 1 week untreated recovery phase. |
| TQB2868 injection+Gemcitabine injection +Albumin paclitaxel injection | Experimental | Drug: TQB2868 injection, Drug: Gemcitabine injection, Drug: Albumin paclitaxel injectionTreatment period TQB2868 injection combined with Gemcitabine injection and Albumin paclitaxel injection, 28 days as a treatment cycle. Maintenance period TQB2868 injection combined with Gemcitabine injection, 21 days as a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must voluntarily participate in the study and sign the informed consent form.
- Aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.
- Diagnosed with pancreatic ductal adenocarcinoma through histological or cytological confirmation.
- Have at least one evaluable metastatic lesion according to RECIST 1.1 criteria;
- No prior systemic anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy). Patients who experience disease progression more than 6 months after completing neoadjuvant or adjuvant therapy are eligible.
Key exclusion criteria (21 listed)
- Subjects with a history of or concurrent diagnosis of other malignant tumors within the past 5 years.
- Unresolved toxicities from prior treatments exceeding Grade 1 according to Common Terminology Criteria (CTC) AE criteria, excluding alopecia.
- Major surgical procedures, significant traumatic injuries, or unhealed wounds or fractures within 28 days prior to the first dose.
- Any bleeding or hemorrhagic event of ≥ Grade 3 according to CTC AE criteria within 4 weeks prior to the first dose.
- Arterial or venous thrombotic events within 6 months prior to the first dose.
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 |
|---|---|---|
| TQB2868 injectionTQB2868 injection is an anti-PD 1/growth factor (GF)-β Receptor Type II (TGF-βRII) bifunctional fusion protein. | Drug | TQB2868 injection+Gemcitabine injection +Albumin paclitaxel injection, TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules |
| Gemcitabine injectionGemcitabine injection | Drug | TQB2868 injection+Gemcitabine injection +Albumin paclitaxel injection, TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules |
| Albumin paclitaxel injectionAlbumin paclitaxel injection | Drug | TQB2868 injection+Gemcitabine injection +Albumin paclitaxel injection, TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules |
| Anlotinib capsulesAnlotinib capsules | Drug | TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules |
Primary outcome
Progression-free survival (PFS)
Time frame: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
The time between the start of treatment and tumorigenesis (in any aspect) progression or death (due to any cause). The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days).
12 secondary outcomes
Objective Response Rate (ORR)
Time frame: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Overall survival (OS)
Time frame: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Duration of Response (DOR)
Time frame: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Disease Control Rate (DCR)
Time frame: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Incidence and severity of adverse events (AEs)
Time frame: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Peak concentration (Cmax)
Time frame: Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
Transforming growth factor-beta (TGF-β)
Time frame: Before first dose, 30 minutes after the first dose, pre-dose at Cycle 2 Day 1, pre-dose at the first efficacy assessment, pre-dose at the time of remission at the first efficacy evaluation, and at the time of progression, each cycle is 28 days.
Incidence of immunogenicity (ADA)
Time frame: Cycle1, 2, 4, 8: Before injection. 30 and 90 days after the last dose
Time to maximum blood concentration (Tmax)
Time frame: Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
Area under the time-concentration curve (AUC0-t）
Time frame: Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
The area under the time-concentration curve ranges from 0 to infinity after administration (AUC0-∞)
Time frame: Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
Plasma drug half-life (T1/2)
Time frame: Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
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 Sep 2025.
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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.
7 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 TQB2868 injection, Gemcitabine injection and Albumin paclitaxel injection in people with Pancreatic Neoplasms, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 7 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 8 inclusion and 21 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Xianjun Yu, Doctor (021-64175590, yuxianjun@fudanpci.org), 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: The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)). 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 Sep 2025.