Non-small Cell Lung Cancer Stage IIIPhase 2ACCESSNCT06998719

Neoadjuvant Durvalumab and Chemotherapy Followed by Surgery/CRT and Durvalumab in Borderline Resectable Stage III NSCLC

A Phase 2 study testing Durvalumab in people with Non-small Cell Lung Cancer Stage III and Borderline Resectable Carcinoma, run by Bi Nan at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

A Phase II, interventional study of neoadjuvant durvalumab (MEDI 4736) and platinum-based Chemotherapy, followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab, in participants with borderline resectable stage III Non-small Cell Lung Cancer (NSCLC) (ACCESS) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer Stage III, Borderline Resectable Carcinoma
What is being tested?: Durvalumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteChina
Study dates: Jul 2025to Dec 2027
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Participant must be ≥ 18 years, at the time of screening. 2. Histologically or cytologically documented NSCLC. 3. Deemed borderline resectable at baseline, confirmed by MDT evaluation at diagnosis.
4. Previously untreated and pathologically confirmed stage III (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology2016)
Nodal status should be investigated with whole body FDG-PET, plus contrast-enhanced computed tomography, and it is optional and decided by investigator that nodal status be proven by biopsy via endobronchial ultrasound, mediastinoscopy, or thoracoscopy.
Mandatory brain MRI with IV contrast, if not available, it is mandatory to take brain computed tomography with IV contrast at the time of staging.
5. WHO or ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dose.
6. Participants must have been confirmed as EGFR/ALK wild type via an appropriately validated local test. Participants with known sensitising EGFR mutations or ALK rearrangements are excluded from the study.

Show all 36Show fewer

7. At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography or MRI and is suitable for accurate repeated measurements.
8. Adequate organ and bone marrow function as follows:
Haemoglobin ≥ 9.0 g/dL.
Absolute neutrophil count ≥ 1.5 × 109/L.
Platelet count ≥ 100×109/L.
Serum bilirubin ≤ 1.5×the ULN or ≤ 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinaemia).
Alanine aminotransferase and AST ≤ 2.5×ULN.
Calculated CrCL > 40 mL/min as determined by Cockcroft Gault (using actual body weight).
Males:
CrCL (mL/min) = Weight (kg) × (140 - Age) 72 × serum creatinine (mg/dL)
Females:
CrCL (mL/min) = Weight (kg) × (140 - Age) × 0.85 72 × serum creatinine (mg/dL) 9. Minimum life expectancy of 12 weeks. 10. The participant should be deemed to have adequate cardiac and lung function, according to a multidisciplinary assessment. A pre- or post-bronchodilator FEV1 of 1.0 L and >40% post-operative predicted value. Use of these cut-off values to assess candidacy for resection on pre-treatment risk assessment. (Surgical Eligible) 11. Minimum body weight of 30 kg. 12. Negative pregnancy test (serum) for FOCBP for female. 13. Male participants who intend to be sexually active with a female partner of child-bearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening, while receiving study intervention, SoC Chemotherapy or CRT, and for 90 days after the last dose of durvalumab and for periods specified in the local prescribing information/SmPC relating to contraception and the time limit for such precautions for SoC agents to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period.
14. Female participants must be for 1 year or more post-menopausal, surgically sterile, or using at least one highly effective method of contraception: a highly effective method of contraception is defined Non-hormonal
Total sexual abstinence (evaluate in relation to the duration of the clinical study and the preferred and usual lifestyle choice of the participant)
Vasectomised sexual partner (with participant assurance that partner received post-vasectomy confirmation of azoospermia)
Tubal occlusion Intrauterine device (provided coils are copper banded) Hormonal
Implants: Etonogestrel-releasing implants (e.g. Implanon® or Norplant®)
Intravaginal devices: Ethinylestradiol/etonogestrel-releasing intravaginal devices (e.g. NuvaRing®)
Injection: Medroxyprogesterone injection (e.g. Depo-Provera®)a
Combined Pill: Normal and low dose combined oral contraceptive pill
Patch: Norelgestromin/ethinylestradiol-releasing transdermal system (e.g. Ortho Evra®)
Mini pill: Progesterone based oral contraceptive pill using desogestrel: Cerazette® is currently the only highly effective progesterone-based Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
Females < 50 years old are considered post-menopausal if they have been amenorrhoeic for 12 months or more prior to enrolment following cessation of exogenous hormonal treatment and follicle-stimulating hormone (FSH) levels in the post-menopausal range.
Females ≥ 50 years old are considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment, or had radiation-induced menopause with last menses > 1 year ago, or had chemotherapy-induced menopause with last menses > 1 year ago.
Female participants of child-bearing potential must agree to use at least one highly effective method of birth control (see Appendix G for complete list of highly effective birth control methods). They should have been stable on their chosen method of birth control for a minimum of 3 months prior to enrollment (screening), while receiving study intervention, SoC Chemotherapy or CRT, and for 90 days after the last dose of durvalumab and for periods specified in the local prescribing information/SmPC relating to contraception and the time limit for such precautions for SoC agents. Cessation of birth control after this point should be discussed with a responsible physician.
Non-sterilised male partners of a female participant of child-bearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) from the time of screening their female partner, while their female partner is receiving study intervention, SoC Chemotherapy or CRT, and for 90 days after the last dose of durvalumab and for periods specified in the local prescribing information/SmPC relating to contraception and the time limit for such precautions for SoC agents.
Periodic abstinence, as well as the rhythm and withdrawal methods are not acceptable methods of birth control..
15. Capable of giving signed informed consent as described in Appendix which includes compliance with the requirements and restrictions listed in the ICF and in this CSP.
16. Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative.
17. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

Existence of more than one primary tumor, such as: mixed small cell and NSCLC histology; synchronous or metachronous tumors that could represent distinct primary tumors.
History of another primary malignancy except for malignancy treated with curative-intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy or adequately treated carcinoma in situ without evidence of disease.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves ' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune pneumonitis, and autoimmune myocarditis). The following are exceptions to this criterion:
Participants with vitiligo or alopecia.
Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.
Any chronic skin condition that does not require systemic therapy.

Show all 38Show fewer

Participants without active disease in the last 5 years may be included but only after consultation with the Study Clinical Lead.
Participants with coeliac disease controlled by diet alone.
Known active hepatitis infection, positive HCV antibody, HBsAg or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Participants co-infected with HBV and HCV, or co-infected with HBV and HDV, namely: HBV positive (presence of HBsAg and/or anti-HBcAb with detectable HBV DNA); AND
HCV positive (presence of anti-HCV antibodies); OR
HDV positive (presence of anti-HDV antibodies).
Known to have tested positive for HIV (positive HIV 1 or 2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
History of active primary immunodeficiency.
Investigator judgement of one or more of the following:
Mean resting corrected QT interval > 470 ms, obtained from triplicate ECGs performed at screening.
History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP.
Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden cardiac death under 40 years of age in first-degree relatives.
Prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines.
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids or local steroid injections (eg, intra-articular injection).
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
Steroids as premedication for hypersensitivity reactions or as an anti-emetic (eg, computed tomography scan premedication).
Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.
Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention.
Any medical contraindication to treatment with platinum-based doublet Chemotherapy, as listed in the local labelling.
Previous treatment in the present study or a previous durvalumab clinical study regardless of treatment arm assignment.
Participation in another clinical study with a study intervention administered in the last 4 weeks prior to first dose of durvalumab or concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Participants with a known hypersensitivity to durvalumab or any excipients of the product(s).
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy. Specifically, regarding the receipt of SoC chemotherapy or chemoradiotherapy, participants should be willing to follow the local prescribing information relating to contraception, the time limits for such precautions, and any additional restrictions for the agents administered.
Participants with a documented test result confirming the presence of a known EGFR or ALK sensitizing mutation is excluded from the study.
Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤28 days prior to the first dose of study drug If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by AstraZeneca/MedImmune and the investigator.
Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:
Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
22. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
History of allogenic organ transplantation. (3) History of leptomeningeal carcinomatosis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shu-Hang Wang, MD contact

8778 8446

cancergcp@163.com

China1 site

Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Nan Bi, MD, PhD, +86 13520445135, binan_email@163.com
Jie He, MD, PhD

Other trials in China

About this study

Official title: A Phase II, Interventional Study of Neoadjuvant Durvalumab and Platinum-based Chemotherapy, Followed by Surgery and Adjuvant Durvalumab or Chemoradiotherapy and Consolidation Durvalumab, in Borderline Resectable Stage III NSCLC (ACCESS)

Read the detailed description

This is a multicenter, Phase II, Chinese study assessing the efficacy and safety of neoadjuvant durvalumab and platinum-based Chemotherapy, given intravenously, followed by either surgery and adjuvant durvalumab or definitive CRT and consolidation durvalumab in participants with borderline resectable stage III NSCLC.

Conditions: Non-small Cell Lung Cancer Stage III, Borderline Resectable Carcinoma
Being tested: Durvalumab
Keywords: Neoadjuvant therapy, Non-small Cell Lung Cancer, Borderline Resectable Carcinoma
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DurvalumabDrug
Also called Surgery, Chemoradiotherapy (CRT)
Neoadjuvant durvalumab (MEDI 4736)and platinum-based chemotherapy, followed by either surgery and adjuvant durvalumab or CRT and consolidation durvalumab, in borderline resectable stage III NSCLC

Study groups in NCT06998719
Study group	Role	What they receive
Cohort 1 (Surgery)	Experimental	After 2 cycles of neoadjuvant durvalumab (1500 mg) + chemotherapy, multidisciplinary team (MDT)-determined participants with resectable tumor (according to MDT re-assessment) will receive a further 1-2 cycles of neoadjuvant durvalumab + chemotherapy followed by surgery. Participants should only go onto surgical resection if the MDT evaluation indicates that an R0 resection is feasible. After surgery, patients will then go on to receive adjuvant durvalumab 1500 mg q4w until recurrence or up to one year (maximum 12 cycles) unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Receives: Drug: Durvalumab
Cohort 2 (CRT)	Active comparator	Participants with unresectable tumor (according to MDT re-assessment) will receive CRT. Participants will receive platinum-based chemotherapy for a maximum of 2 cycles. Radiotherapy at a dose of 5 fractions/week for ~6 weeks (± 3 days) (total 60 Gy± 10%) can be given sequentially or concurrently with chemotherapy. After CRT, patients will receive consolidation durvalumab 1500 mg q4w until disease progression or up to one year (maximum 12 cycles) unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Receives: Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Resection rate
To assess the efficacy of neoadjuvant durvalumab + chemotherapy in terms of resection rate in participants with borderline resectable stage III NSCLC.
Measured: Through study completion, an average of 1 year.

Secondary outcomes (1)

R0 resection rate.
To investigate surgical outcomes.R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.R0 resection rate =The number of subjects whose lesions were completely removed/the number of subjects who participated in the surgery
Measured: Through study completion, an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2025Dec 2027

First posted31 May 2025
Study startJul 2025 (estimated)
Primary completionMay 2026 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-small Cell Lung Cancer Stage IIIStudies 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06998719
Sponsor's protocol ID: NCC5253
Acronym: ACCESS
Status last verified: May 2025
First submitted: 21 Apr 2025
Last updated: 31 May 2025
Results posted: No
Data monitoring committee: 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 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Interventional Study of Neoadjuvant Durvalumab and Platinum-based Chemotherapy, Followed by Surgery and Adjuvant Durvalumab or Chemoradiotherapy and Consolidation Durvalumab, in Borderline Resectable Stage III NSCLC (ACCESS)
ClinicalTrials.gov ID: NCT06998719
Acronym / sponsor ID: ACCESS / NCC5253
Conditions: Non-small Cell Lung Cancer Stage III, Borderline Resectable Carcinoma
Keywords: Neoadjuvant therapy, Non-small Cell Lung Cancer, Borderline Resectable Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Bi NanUniversity, hospital or other
Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study start: Jul 2025 (estimated)
Primary completion: May 2026 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 31 May 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1 (Surgery)	Experimental	Drug: DurvalumabAfter 2 cycles of neoadjuvant durvalumab (1500 mg) + chemotherapy, multidisciplinary team (MDT)-determined participants with resectable tumor (according to MDT re-assessment) will receive a further 1-2 cycles of neoadjuvant durvalumab + chemotherapy followed by surgery. Participants should only go onto surgical resection if the MDT evaluation indicates that an R0 resection is feasible. After surgery, patients will then go on to receive adjuvant durvalumab 1500 mg q4w until recurrence or up to one year (maximum 12 cycles) unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
Cohort 2 (CRT)	Active comparator	Drug: DurvalumabParticipants with unresectable tumor (according to MDT re-assessment) will receive CRT. Participants will receive platinum-based chemotherapy for a maximum of 2 cycles. Radiotherapy at a dose of 5 fractions/week for ~6 weeks (± 3 days) (total 60 Gy± 10%) can be given sequentially or concurrently with chemotherapy. After CRT, patients will receive consolidation durvalumab 1500 mg q4w until disease progression or up to one year (maximum 12 cycles) unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (36 listed)

1. Participant must be ≥ 18 years, at the time of screening. 2. Histologically or cytologically documented NSCLC. 3. Deemed borderline resectable at baseline, confirmed by MDT evaluation at diagnosis.
4. Previously untreated and pathologically confirmed stage III (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology2016)
5. WHO or ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dose.
6. Participants must have been confirmed as EGFR/ALK wild type via an appropriately validated local test. Participants with known sensitising EGFR mutations or ALK rearrangements are excluded from the study.
7. At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography or MRI and is suitable for accurate repeated measurements.

Key exclusion criteria (38 listed)

22. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.

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
DurvalumabAlso: Surgery, Chemoradiotherapy (CRT)Neoadjuvant durvalumab (MEDI 4736)and platinum-based chemotherapy, followed by either surgery and adjuvant durvalumab or CRT and consolidation durvalumab, in borderline resectable stage III NSCLC	Drug	Cohort 1 (Surgery), Cohort 2 (CRT)

Primary outcome

Resection rate
Time frame: Through study completion, an average of 1 year.
To assess the efficacy of neoadjuvant durvalumab + chemotherapy in terms of resection rate in participants with borderline resectable stage III NSCLC.

1 secondary outcome

R0 resection rate.
Time frame: Through study completion, an average of 1 year.

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 31 May 2025.
Individual participant dataSharing planned: No

Related trials for Non-small Cell Lung Cancer Stage III

RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
Non Small Cell Lung Cancer
Not yet recruiting
Moderately Hypofractionated Versus Conventional Chemoradiotherapy With Consolidation Immunotherapy in Patients With Unresectable, Non-Targetable Stage III Non Small Cell Lung Cancer (NSCLC)
Stage III NSCLC

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.

Shu-Hang Wang, MD contact

8778 8446

cancergcp@163.com

Jie He, MD principal investigator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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 Durvalumab in people with Non-small Cell Lung Cancer Stage III and Borderline Resectable Carcinoma, run by Bi Nan 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 36 inclusion and 38 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 31 May 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 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 Shu-Hang Wang, MD (8778 8446, cancergcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resection rate (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06998719.

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 31 May 2025.