Intrahepatic CholangiocarcinomaPhase 3NCT05342194
Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study
A Phase 3 study testing Toripalimab, Lenvatinib mesylate capsules and Oxaliplatin for injection in people with Intrahepatic Cholangiocarcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is a Phase III, prospective, randomized, three-arm, double-blind, placebo-controlled, international multicenter study to evaluate the efficacy and safety of toripalimab in combination with lenvatinib and gemcitabine-based chemotherapy compared with gemcitabine-based chemotherapy as first-line treatment for… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- Toripalimab, Lenvatinib mesylate capsules and Oxaliplatin for injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2023to 31 May 2027
- 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
- Age of 18-75 years (inclusive), male or female;
- Volunteer to participate in the study by signing the informed consent form and the ability to comply with the study protocol;
- Advanced ICC with diagnosis confirmed by histology or cytology;
- Stage II, III, or IV per TNM staging for ICC of the American Joint Committee on Cancer (AJCC) (8th edition, 2017). Those with Stage II or III should be determined to be unresectable by the investigator;
- Patients with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization) for ICC. Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible;
- Measurable lesion per RECIST v1.1;
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- Child-Pugh class A with no history of hepatic encephalopathy;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1;
- Life expectancy ≥12 weeks;
Who cannot join
- Diagnosis of hepatocellular carcinoma (HCC), mixed cholangiocarcinoma and HCC, sarcomatoid hepatocellular carcinoma, or hepatic fibrolamellar carcinoma by histology or cytology;
- History of malignancy other than ICC within 5 years prior to screening, with the exception of localized malignancies that have been cured, including non-melanoma skin cancers, cervical carcinoma in situ, breast carcinoma in situ, and papillary thyroid carcinoma;
- Prior radiotherapy for ICC within 4 weeks prior to randomization;
- Major surgical procedures within 4 weeks prior to randomization;
- Side effects from prior therapy (except alopecia and pigmentation) that has not recovered to ≤ grade 1 (per NCI-CTCAE v5.0) or levels specified in the inclusion/exclusion criteria;
- Uncontrolled pericardial effusion, pleural effusion, or clinically significant moderate or severe ascites that is symptomatic or requires thoracentesis or paracentesis during the screening phase for control of symptoms;
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- Gastrointestinal (GI) hemorrhage within 6 months prior to randomization and/or gastrointestinal varices that have not been assessed and treated, if appropriate, within 6 months prior to randomization.
- Gastrointestinal or non-gastrointestinal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to randomization;
- Ongoing or a history of recurrent intestinal obstruction. Patients with a single episode of intestinal obstruction that has fully resolved following treatment are eligible allowed;
- History of serious cardiovascular and cerebrovascular diseases:
- Significant bleeding and coagulopathy or other evidence of bleeding diathesis, to include:
- Pre-existing CNS metastases and/or meningeal metastases (including dural metastases and leptomeningeal metastases);
- Serious non-healing wound, active ulcer, or untreated bone fracture;
- Vaccination with live virus or bacteria within 30 days prior to randomization;
- Active autoimmune disease or history of autoimmune disease
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
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 130061
Jian Zhou, doctor, +86 021-64041990, zhou.jian@zs-hospital.sh.cn
About this study
Official title: A Phase III, Randomized, Three-arm, Double-blind, Placebo-controlled, International Multi-center Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Lenvatinib and Gemcitabine-based Chemotherapy Compared With Gemcitabine-based Chemotherapy as First-line Treatment in Patients With Unresectable Advanced Intrahepatic Cholangiocarcinoma (ICC)
This is a Phase III, prospective, randomized, three-arm, double-blind, placebo-controlled, international multicenter study to evaluate the efficacy and safety of toripalimab in combination with lenvatinib and gemcitabine-based chemotherapy compared with gemcitabine-based chemotherapy as first-line treatment for unresectable advanced ICC.
This study will enroll approximately 480 patients with unresectable advanced ICC who have received no prior systemic therapy. Patients who meet the requirements will be randomly assigned to Treatment Arm A: Toripalimab, lenvatinib, and gemcitabine-based chemotherapy or Treatment Arm B: Toripalimab, oral placebo, and gemcitabine-based chemotherapy or Treatment Arm C: Intravenous placebo, oral placebo, and gemcitabine-based chemotherapy.
Read more
All patients will receive standard chemotherapy (GEMOX or GC per Investigator decision) for a maximum of 8 cycles. After the completion of standard chemotherapy, all patients continue to receive maintenance therapy with toripalimab injection or its placebo in combination with lenvatinib mesylate capsule or its placebo until unacceptable toxicity, confirmed disease progression and loss of clinical benefit as determined by the investigators, start of new anti-cancer therapy, death, other conditions requiring termination of study treatment, or the patient meets the criteria for study withdrawal, whichever occurs first.
In the absence of unacceptable toxicity, patients who meet criteria for unconfirmed disease progression per RECIST v1.1 while receiving toripalimab, lenvatinib, or their placebos will be permitted to continue treatment if their clinical status or symptoms are stable or improved (as determined by the investigators) or until loss of clinical benefit. Patients with confirmed disease progression should discontinue toripalimab, lenvatinib, or their placebos.
Tumor assessments will be performed at screening and during the study treatment per protocol. In the absence of progression, tumor assessments will continue as scheduled, regardless of whether study treatment ends, until confirmed disease progression or other criteria for study withdrawal are met, whichever occurs first. Patients who meet RECIST v1.1 criteria for progression should undergo tumor assessments as scheduled if clinical benefits of continuing study treatment are determined by investigators until progression is confirmed per iRECIST (iCPD), or the criteria for study withdrawal are met, whichever occurs first.
Computerized tomography (CT)/magnetic resonance imaging (MRI) scans for efficacy evaluation will be performed at baseline, every 6 weeks (Q6W) in the first year (52 weeks), and every 9 weeks (Q9W) in the second year (after week 52).
All AEs and concomitant medications during the study will be recorded. An end-of-treatment (EOT) visit will be performed within 30 days after the last dose of study treatment or termination of study treatment is confirmed by the investigator. After the EOT visit, follow-up for survival (telephone visit is allowed) will be conducted and AEs and subsequent anti-cancer therapy will be collected.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Toripalimab, Lenvatinib mesylate capsules, Placebo IV, Oral placebo, Oxaliplatin for injection
- Keywords
- Intrahepatic cholangiocarcinoma, Toripalimab, lenvatinib, Chemotherapy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called Tuoyi
240 mg IV on day 1 of each 21-day treatment cycle (Q3W) for up to 35 treatment cycles
Lenvatinib mesylate capsulesDrug
Also called LENVIMA
8 mg orally (po) once daily (QD)
Placebo IVDrug
Also called Toripalimab placebo
Placebo IV on day 1 of each 21-day treatment cycle (Q3W) for up to 35 treatment cycles
Oral placeboDrug
Also called Lenvatinib mesylate capsules placebo
Oral placebo po QD continuously
Oxaliplatin for injectionDrug
85 mg/m2 IV, on day 1 of each 21-day treatment cycle (Q3W) up to 8 cycles
1 g/m2 IV, on day 1 and day8 of each 21-day treatment cycle (Q3W) up to 8 cycles
CisplatinDrug
25 mg/m2 IV, on day 1 and day8 of each 21-day treatment cycle (Q3W) up to 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab, lenvatinib, and gemcitabine-based chemotherapy-Arm A | Experimental | Toripalimab plus lenvatinib and GEMOX (Gemcitabine hydrochloride and Oxaliplatin for injection ) or GC (Gemcitabine hydrochloride and Cisplatin) Receives: Drug: Toripalimab; Drug: Lenvatinib mesylate capsules; Drug: Oxaliplatin for injection; Drug: Gemcitabine hydrochloride; Drug: Cisplatin |
| Toripalimab, oral placebo, and gemcitabine-based chemotherapy -Arm B | Experimental | Toripalimab plus lenvatinib placebo and GEMOX (Gemcitabine hydrochloride and Oxaliplatin for injection ) or GC (Gemcitabine hydrochloride and Cisplatin) Receives: Drug: Toripalimab; Drug: Oral placebo; Drug: Oxaliplatin for injection; Drug: Gemcitabine hydrochloride; Drug: Cisplatin |
| Intravenous placebo, oral placebo, and gemcitabine-based chemotherapy-Arm C | Active comparator | Toripalimab placebo plus lenvatinib placebo and GEMOX (Gemcitabine hydrochloride and Oxaliplatin for injection ) or GC (Gemcitabine hydrochloride and Cisplatin) Receives: Drug: Placebo IV; Drug: Oral placebo; Drug: Oxaliplatin for injection; Drug: Gemcitabine hydrochloride; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) in Arm A compared with Arm C (OS A vs. C)
OS is defined as the time from randomization to death due to any cause. Overall survival will be compared between Arm A and Arm C
Measured: Until 2 years after the last subject was enrolled
Secondary outcomes (5)
OS in Arm B compared with Arm C (OS B vs. C)
OS is defined as the time from randomization to death due to any cause. Overall survival will be compared between Arm B and Arm C
Measured: Until 2 years after the last subject was enrolled
Investigator-determined progression-free survival (PFS)
Investigator-determined progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) in Arm A compared with Arm C (PFS A vs. C);
Measured: Until 2 years after the last subject was enrolled
Investigator-determined progression-free survival (PFS)
Investigator-determined PFS according to RECIST v1.1 in Arm B compared with Arm C (PFS B vs. C);
Measured: Until 2 years after the last subject was enrolled
Investigator-determined objective response rate (ORR)
Investigator-determined objective response rate (ORR) according to RECIST v1.1 in Arm A compared with Arm C (ORR A vs. C)
Measured: Until 2 years after the last subject was enrolled
Investigator-determined objective response rate (ORR)
Investigator-determined ORR according to RECIST v1.1 in Arm B compared with Arm C (ORR B vs. C)
Measured: Until 2 years after the last subject was enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start19 Jun 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- 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
- Model description
- Parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342194
- Sponsor's protocol ID
- JS001-039-III-ICC
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2022
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Three-arm, Double-blind, Placebo-controlled, International Multi-center Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Lenvatinib and Gemcitabine-based Chemotherapy Compared With Gemcitabine-based Chemotherapy as First-line Treatment in Patients With Unresectable Advanced Intrahepatic Cholangiocarcinoma (ICC)
- ClinicalTrials.gov ID
- NCT05342194
- Acronym / sponsor ID
- JS001-039-III-ICC
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- Intrahepatic cholangiocarcinoma, Toripalimab, lenvatinib, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 22 Apr 2022 (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, prospective, randomized, three-arm, double-blind, placebo-controlled, international multicenter study to evaluate the efficacy and safety of toripalimab in combination with lenvatinib and gemcitabine-based chemotherapy compared with gemcitabine-based chemotherapy as first-line treatment for unresectable advanced ICC.
This study will enroll approximately 480 patients with unresectable advanced ICC who have received no prior systemic therapy. Patients who meet the requirements will be randomly assigned to Treatment Arm A: Toripalimab, lenvatinib, and gemcitabine-based chemotherapy or Treatment Arm B: Toripalimab, oral placebo, and gemcitabine-based chemotherapy or Treatment Arm C: Intravenous placebo, oral placebo, and gemcitabine-based chemotherapy.
All patients will receive standard chemotherapy (GEMOX or GC per Investigator decision) for a maximum of 8 cycles. After the completion of standard chemotherapy, all patients continue to receive maintenance therapy with toripalimab injection or its placebo in combination with lenvatinib mesylate capsule or its placebo until unacceptable toxicity, confirmed disease progression and loss of clinical benefit as determined by the investigators, start of new anti-cancer therapy, death, other conditions requiring termination of study treatment, or the patient meets the criteria for study withdrawal, whichever occurs first.
In the absence of unacceptable toxicity, patients who meet criteria for unconfirmed disease progression per RECIST v1.1 while receiving toripalimab, lenvatinib, or their placebos will be permitted to continue treatment if their clinical status or symptoms are stable or improved (as determined by the investigators) or until loss of clinical benefit. Patients with confirmed disease progression should discontinue toripalimab, lenvatinib, or their placebos.
Tumor assessments will be performed at screening and during the study treatment per protocol. In the absence of progression, tumor assessments will continue as scheduled, regardless of whether study treatment ends, until confirmed disease progression or other criteria for study withdrawal are met, whichever occurs first. Patients who meet RECIST v1.1 criteria for progression should undergo tumor assessments as scheduled if clinical benefits of continuing study treatment are determined by investigators until progression is confirmed per iRECIST (iCPD), or the criteria for study withdrawal are met, whichever occurs first.
Computerized tomography (CT)/magnetic resonance imaging (MRI) scans for efficacy evaluation will be performed at baseline, every 6 weeks (Q6W) in the first year (52 weeks), and every 9 weeks (Q9W) in the second year (after week 52).
All AEs and concomitant medications during the study will be recorded. An end-of-treatment (EOT) visit will be performed within 30 days after the last dose of study treatment or termination of study treatment is confirmed by the investigator. After the EOT visit, follow-up for survival (telephone visit is allowed) will be conducted and AEs and subsequent anti-cancer therapy will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| Toripalimab, lenvatinib, and gemcitabine-based chemotherapy-Arm A | Experimental | Drug: Toripalimab, Drug: Lenvatinib mesylate capsules, Drug: Oxaliplatin for injection, Drug: Gemcitabine hydrochloride, Drug: CisplatinToripalimab plus lenvatinib and GEMOX (Gemcitabine hydrochloride and Oxaliplatin for injection ) or GC (Gemcitabine hydrochloride and Cisplatin) |
| Toripalimab, oral placebo, and gemcitabine-based chemotherapy -Arm B | Experimental | Drug: Toripalimab, Drug: Oral placebo, Drug: Oxaliplatin for injection, Drug: Gemcitabine hydrochloride, Drug: CisplatinToripalimab plus lenvatinib placebo and GEMOX (Gemcitabine hydrochloride and Oxaliplatin for injection ) or GC (Gemcitabine hydrochloride and Cisplatin) |
| Intravenous placebo, oral placebo, and gemcitabine-based chemotherapy-Arm C | Active comparator | Drug: Placebo IV, Drug: Oral placebo, Drug: Oxaliplatin for injection, Drug: Gemcitabine hydrochloride, Drug: CisplatinToripalimab placebo plus lenvatinib placebo and GEMOX (Gemcitabine hydrochloride and Oxaliplatin for injection ) or GC (Gemcitabine hydrochloride and Cisplatin) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of 18-75 years (inclusive), male or female;
- Volunteer to participate in the study by signing the informed consent form and the ability to comply with the study protocol;
- Advanced ICC with diagnosis confirmed by histology or cytology;
- Stage II, III, or IV per TNM staging for ICC of the American Joint Committee on Cancer (AJCC) (8th edition, 2017). Those with Stage II or III should be determined to be unresectable by the investigator;
- Patients with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization) for ICC. Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible;
Key exclusion criteria (15 listed)
- Diagnosis of hepatocellular carcinoma (HCC), mixed cholangiocarcinoma and HCC, sarcomatoid hepatocellular carcinoma, or hepatic fibrolamellar carcinoma by histology or cytology;
- History of malignancy other than ICC within 5 years prior to screening, with the exception of localized malignancies that have been cured, including non-melanoma skin cancers, cervical carcinoma in situ, breast carcinoma in situ, and papillary thyroid carcinoma;
- Prior radiotherapy for ICC within 4 weeks prior to randomization;
- Major surgical procedures within 4 weeks prior to randomization;
- Side effects from prior therapy (except alopecia and pigmentation) that has not recovered to ≤ grade 1 (per NCI-CTCAE v5.0) or levels specified in the inclusion/exclusion criteria;
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 |
|---|---|---|
| ToripalimabAlso: Tuoyi240 mg IV on day 1 of each 21-day treatment cycle (Q3W) for up to 35 treatment cycles | Drug | Toripalimab, lenvatinib, and gemcitabine-based chemotherapy-Arm A, Toripalimab, oral placebo, and gemcitabine-based chemotherapy -Arm B |
| Lenvatinib mesylate capsulesAlso: LENVIMA8 mg orally (po) once daily (QD) | Drug | Toripalimab, lenvatinib, and gemcitabine-based chemotherapy-Arm A |
| Placebo IVAlso: Toripalimab placeboPlacebo IV on day 1 of each 21-day treatment cycle (Q3W) for up to 35 treatment cycles | Drug | Intravenous placebo, oral placebo, and gemcitabine-based chemotherapy-Arm C |
| Oral placeboAlso: Lenvatinib mesylate capsules placeboOral placebo po QD continuously | Drug | Intravenous placebo, oral placebo, and gemcitabine-based chemotherapy-Arm C, Toripalimab, oral placebo, and gemcitabine-based chemotherapy -Arm B |
| Oxaliplatin for injection85 mg/m2 IV, on day 1 of each 21-day treatment cycle (Q3W) up to 8 cycles | Drug | Intravenous placebo, oral placebo, and gemcitabine-based chemotherapy-Arm C, Toripalimab, lenvatinib, and gemcitabine-based chemotherapy-Arm A, Toripalimab, oral placebo, and gemcitabine-based chemotherapy -Arm B |
| Gemcitabine hydrochloride1 g/m2 IV, on day 1 and day8 of each 21-day treatment cycle (Q3W) up to 8 cycles | Drug | Intravenous placebo, oral placebo, and gemcitabine-based chemotherapy-Arm C, Toripalimab, lenvatinib, and gemcitabine-based chemotherapy-Arm A, Toripalimab, oral placebo, and gemcitabine-based chemotherapy -Arm B |
| Cisplatin25 mg/m2 IV, on day 1 and day8 of each 21-day treatment cycle (Q3W) up to 8 cycles | Drug | Intravenous placebo, oral placebo, and gemcitabine-based chemotherapy-Arm C, Toripalimab, lenvatinib, and gemcitabine-based chemotherapy-Arm A, Toripalimab, oral placebo, and gemcitabine-based chemotherapy -Arm B |
Primary outcome
Overall survival (OS) in Arm A compared with Arm C (OS A vs. C)
Time frame: Until 2 years after the last subject was enrolled
OS is defined as the time from randomization to death due to any cause. Overall survival will be compared between Arm A and Arm C
5 secondary outcomes
OS in Arm B compared with Arm C (OS B vs. C)
Time frame: Until 2 years after the last subject was enrolled
Investigator-determined progression-free survival (PFS)
Time frame: Until 2 years after the last subject was enrolled
Investigator-determined progression-free survival (PFS)
Time frame: Until 2 years after the last subject was enrolled
Investigator-determined objective response rate (ORR)
Time frame: Until 2 years after the last subject was enrolled
Investigator-determined objective response rate (ORR)
Time frame: Until 2 years after the last subject was enrolled
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 23 Apr 2025.
- Individual participant dataSharing planned: No
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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 3 study testing Toripalimab, Lenvatinib mesylate capsules and Oxaliplatin for injection in people with Intrahepatic Cholangiocarcinoma, run by Shanghai Junshi Bioscience Co., Ltd. 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 9 inclusion and 15 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 23 Apr 2025. 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 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 Jiazheng Yan (+86 158 2259 6147, jiazheng_yan@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) in Arm A compared with Arm C (OS A vs. C) (time frame: Until 2 years after the last subject was enrolled). 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 23 Apr 2025.