A Phase 2 interventional study of Trastuzumab Rezetecan (SHR-A1811) and Trastuzumab Rezetecan (SHR-A1811) + Adebrelimab in Gastric Adenocarcinoma and Gastroesophageal Junction (GEJ) Adenocarcinoma, sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
Among 77 studies in Adenocarcinoma with a site in China — 33 open to participants now, 42 under way, 12 of them phase 3. Adenocarcinoma · China.
Among the 77 studies in Adenocarcinoma with a site in China, this one is the 43rd largest by planned enrollment of the 68 interventional ones that give a count, is one of 9 that started in 2026, is one of 26 in phase 2, reaches primary completion later than 33 of the 41 other live ones, and was the 76th registered.
620 studies on the registry are indexed under Adenocarcinoma; 148 are open to participants now.
Browse Adenocarcinoma studies →33 of the 77 studies in Adenocarcinoma with a site in China are open now. Recruiting first, the newest first:
Astellas Pharma Global Development, Inc. · Sites in China, United States, Japan and 1 more country
Ages 18+
Shanghai Zhongshan Hospital · Sites in China
Ages 55+ · Men only
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Sites in China
Ages 18+
AstraZeneca · Sites in China, United States, Australia and 21 more countries
Ages 18+
Shanghai Zhongshan Hospital · Sites in China
Ages 18–80
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 110 Adenocarcinoma studies recruiting now, 81 (74%) set no upper age limit and 11 (10%) stop at 75 or younger; 7 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
77 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 37 · Phase 3 21 · Phase 4 4
First in 2006; this study’s year is marked. 9 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 62 is close to the median of 57 across 490 interventional studies indexed under Adenocarcinoma.
Median enrollment 98 across the 68 interventional studies, 250 across the 9 observational. Of the 20 that completed or were terminated, 7 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
30 of 77 have an industry lead sponsor. The 10 most frequent:
Fudan University is the lead sponsor of 1,316 studies on the registry; 644 are open to participants now.
Fudan University has 6 studies filed under Adenocarcinoma — fewer than ten, so there is no comparison to draw.
9 of the studies in Adenocarcinoma with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04208347Phase 3Ruijin HospitalPerioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer | 2026-12 |
| NCT06177041Phase 3FutureGen Biopharmaceutical (Beijing) Co., LtdM108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. | 2027-01-11 |
| NCT07363382First Affiliated Hospital of Fujian Medical UniversityThe Value of GRPR PET Imaging for Diagnosis and Staging in Prostate Cancer | 2026-12-31 |
| NCT07444983Fujian Medical University Union HospitalRezvilutamide for High-Risk Prostate Cancer After Surgery | 2027-02-11 |
| NCT06926374Chinese University of Hong KongProspective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery | 2027-04 |
Add all 9 to your calendar (.ics) → With an account.
Among the 77 studies in Adenocarcinoma with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This single-center, dual-cohort, exploratory phase II trial evaluates the efficacy and safety of trastuzumab rezetecan (SHR-A1811), an anti-HER2 antibody-drug conjugate (ADC), with or without the anti-PD-L1 antibody adebrelimab as neoadjuvant therapy in patients with locally advanced, resectable esophageal, gastric, or gastroesophageal junction (GEJ) adenocarcinoma. Approximately 62 patients aged ≥18 years with pathologically confirmed resectable disease (cT1b-2N+M0 or cT3-4NanyM0, American Joint Committee on Cancer [AJCC] 8th edition), HER2 intermediate-to-high expression (immunohistochemistry [IHC] 2+ or 3+), no prior systemic antitumor therapy for esophageal or gastric adenocarcinoma, and Eastern Cooperative Oncology Group (ECOG) performance status 0-1 are planned for enrollment. Eligible participants will be randomly assigned to receive either trastuzumab rezetecan monotherapy or trastuzumab rezetecan plus adebrelimab for 3 cycles (each cycle 21 days), followed by radical surgery. The primary endpoint is pathological complete response (pCR). Secondary endpoints include major pathological response (MPR), R0 resection rate, objective response rate (ORR), event-free survival (EFS), overall survival (OS), and safety. Exploratory objectives include biomarker analysis to identify predictors of response to HER2 ADC therapy with or without PD-L1 blockade.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Note: Bone scan is required if bone lesions are suspected; diagnostic laparoscopy is required if peritoneal is suspected or for Lauren diffuse-type tumors.
5. intermediate-to-high expression by immunohistochemistry (IHC) 2+ or 3+. 6. No prior antitumor therapy for esophageal or gastric adenocarcinoma. 7. Availability of tumor tissue (primary tumor or metastatic lymph node) for pathological testing, including paraffin block, paraffin-embedded sections, or fresh tissue sections; is preferred. If unavailable, a new baseline biopsy is required.
8. No severe cardiac dysfunction; (left ventricular ejection fraction, LVEF) ≥55% within 28 days before study drug administration.
9. Adequate organ function within 7 days before study drug administration, defined as:
Hematologic function:
(ANC) ≥1.5 × 10⁹/L count ≥100 × 10⁹/L ≥90 g/L No blood or component transfusion within 14 days before the first dose, and no treatment with hematopoietic growth factors (e.g., granulocyte colony-stimulating factor (G-CSF) , erythropoietin) within 7 days before the first dose.
Hepatic function:
Total (TBIL) ≤1.5 × (ULN) (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.
Renal function:
Serum creatinine (Cr) ≤1.5 × ULN, or (CrCl) ≥50 mL/min (calculated by the Cockcroft-Gault formula).
Coagulation function:
(INR) ≤1.5 × ULN and activated partial thromboplastin time (APTT) ≤1.5 × ULN (except for patients receiving therapeutic anticoagulation).
Urine protein \<2+; if urine protein ≥2+, 24-hour urine protein must be ≤1 g. 10. Male participants and women of (including premenopausal women and women within 2 years after menopause) must agree to use effective from the time of informed consent signing until 6 months after the last dose of study drug. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of study drug.
Exclusion Criteria:
History of primary immunodeficiency or active disease; or current use of or systemic (≥10 mg/day prednisone or equivalent) that continued within 2 weeks before enrollment.
Note: Patients with type 1 diabetes mellitus, stable hypothyroidism on hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis not requiring systemic treatment, or vitiligo are eligible.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this cohort will receive trastuzumab rezetecan (SHR-A1811) 4.8 mg/kg intravenously on day 1 of each 21-day cycle, for a total of 3 cycles as neoadjuvant therapy, followed by radical surgery.
Drug: Trastuzumab Rezetecan (SHR-A1811)
Participants in this cohort will receive trastuzumab rezetecan (SHR-A1811) 4.8 mg/kg + adebrelimab 1200 mg intravenously on day 1 of each 21-day cycle, for a total of 3 cycles as neoadjuvant therapy, followed by radical surgery.
Drug: Trastuzumab Rezetecan (SHR-A1811) + Adebrelimab
Trastuzumab rezetecan for injection, an anti-HER2 antibody-drug conjugate (ADC). Administered as 4.8 mg/kg intravenous infusion (IV) on Day 1 of each 21-day cycle (Q3W), for 3 neoadjuvant cycles before radical surgery. In patients without progression who achieve R0 resection, the same dose and schedule are continued as adjuvant therapy.
Drug page: Trastuzumab rezetecan
Trastuzumab rezetecan (SHR-A1811) is an anti-HER2 ADC administered at 4.8 mg/kg IV on Day 1 of each 21-day cycle (Q3W). Adebrelimab is a humanized anti-PD-L1 monoclonal antibody administered at 1200 mg IV on Day 1 of each 21-day cycle (Q3W). Both agents are given concurrently for 3 neoadjuvant cycles before radical surgery. In patients who undergo R0 resection without disease progression, the same regimen and schedule are continued as adjuvant therapy.
Pathological complete response (pCR) rate
Central pathological review; pCR defined as ypT0N0 (no residual viable tumor in primary tumor bed and sampled lymph nodes) per American Joint Committee on Cancer (AJCC) 9th edition
Time frame: Assessed at surgery (approximately 3-4 weeks after completion of Cycle 3; each cycle is 21 days, total approximately 12-13 weeks after treatment initiation)
Major pathological response (MPR) rate
Central pathology; MPR defined as ≤10% residual viable tumor cells in primary tumor bed
Time frame: Assessed at surgery (approximately 3-4 weeks after completion of Cycle 3; each cycle is 21 days, total approximately 12-13 weeks after treatment initiation)
R0 resection rate
R0 defined as microscopic margin-negative resection
Time frame: Assessed at surgery (approximately 3-4 weeks after completion of Cycle 3; each cycle is 21 days, total approximately 12-13 weeks after treatment initiation)
Objective response rate (ORR)
Imaging (CT/MRI/PET-CT) per RECIST 1.1
Time frame: Assessed at baseline and after 3 neoadjuvant cycles (each cycle is 21 days, total approximately 9 weeks after treatment initiation)
Event-free survival (EFS)
Time from first study drug administration to disease progression precluding surgery, recurrence, or death from any cause, whichever occurs first.
Time frame: From treatment initiation to progression, recurrence, or death, assessed up to 24 months
Overall survival (OS)
The time from the date of first study drug administration (treatment initiation) to the date of death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.
Time frame: From treatment initiation to death from any cause, assessed up to 24 months
Incidence of adverse events (AEs)
Time frame: From first dose to 90 days after last dose (each cycle is 21 days, total approximately 132 days after treatment initiation)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2028, 23 months later.
Of 71 non-industry phase 2 interventional studies under Adenocarcinoma, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 48 and three quarters within 94. This study's planned 23 months is below that.
Counting every sponsor, half of 93 studies reached it within 60 months; a quarter within 35 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trastuzumab rezetecan