Gastric AdenocarcinomaPhase 2/3RESOLVE-2NCT03691454
Compare Neoadjuvant DOS Combined With Toripalimab Versus SOX Combined With Toripalimab in Locally Advanced Gastric Adenocarcinoma
A Phase 2/3 study testing Docetaxel+Oxaliplatin+S-1+Toripalimab and Oxaliplatin+S-1+Toripalimab in people with Gastric Adenocarcinoma, run by Peking University at 1 site in China.
Trial summary
This is a randomized, multicenter, controlled, adaptive phase II/III clinical study. The aim is to compare neoadjuvant chemotherapy with docetaxel, oxaliplatin, and S-1 (DOS) plus toripalimab versus oxaliplatin and S-1 (SOX) plus toripalimab in patients with locally advanced gastric adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Docetaxel+Oxaliplatin+S-1+Toripalimab and Oxaliplatin+S-1+Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2018to 30 Jun 2027
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory males or females with ages ≥ 18.
- Karnofsky Performance Scale（KPS） ≥ 70.
- Pathologically confirmed gastric adenocarcinoma (including Lauren classification), with a confirmed HER2-negative status (IHC 0, 1+, or 2+ with FISH negative).
- A clinical stage of cIII/IVa (AJCC 8th edition gastric cancer TNM staging) diagnosed by enhanced CT/MRI, combined with endoscopic ultrasound (EUS) and diagnostic laparoscopy if necessary.
- For gastroesophageal junction (GEJ) cancer, only patients with Siewert type III or Siewert type II disease not requiring combined thoracotomy are eligible for enrollment.
- The tumor can undergo radical resection.
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- The surgeon and the center is experienced and qualified for gastrectomy with D2 lymphadenectomy (the number of lymph nodes examined must at least be 15, so as to ensure the quality of the surgery).
- Performance status and adequate organ function to tolerate major abdominal surgery.
- Results of blood routine tests and biochemistry at baseline meet the following standards: hemoglobin (Hb) ≥ 90g/L; absolute neutrophil count (ANC) ≥ 2×10⁹/L; platelet count ≥ 100×10⁹/L; ALT/AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; serum total bilirubin (STB) < 1×ULN; serum creatinine < 1×ULN; and serum albumin ≥ 30g/L.
- Left ventricular ejection fraction (LVEF) ≥ 50% confirmed by echocardiography.
- Not having any serious concomitant disease that makes the survival less than five years.
- Be willing to and able to abide by the protocol throughout the study.
- Having given written informed consent prior to screening and understood that he or she will be free to withdraw from the study at any time without suffering any loss.
- Agree to provide blood and histological samples.
Who cannot join
- Pregnancy or lactation women.
- Women of childbearing potential who are positive for the pregnancy test at the baseline or fail to take the test; women after the menopause must have stopped menstruating for at least 12 months that they will be believed to be unable to get pregnant;
- Sexually active (potentially fertile) males and females who are unwilling to take any method of contraception during the study;
- Patients who were previously allergic to monoclonal antibody;
- Patients with active autoimmune diseases;
- Patients with any signs of distant metastatic lesions;
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- Patients who previously received cytotoxic chemotherapy, radiotherapy or immunotherapy for the treatment of the present gastric adenocarcinoma, excluding corticosteroids;
- A medical history of other malignant disease in the last five years, excluding cured skin cancer and carcinoma in situ (CIS);
- Having uncontrolled epilepsy, central nervous system disease or mental disorder, whether which is clinically serious enough to affect signature of informed consent form or the patient's compliance with oral administration of the study drug will be judged;
- Having clinically serious (active) heart disease, such as symptomatic coronary heart disease (CHD), NYHA (New York Heart Association) II or more serious congestive heart failure, or serious arrhythmia that requires drug interventions, or a medical history of myocardial infraction (MI) during the last 12 months.
- Patients who have upper gastrointestinal obstruction, or physiological dysfunction, or malabsorption syndrome, which may affect absorption of S-1.
- Patients with active infections (such as hepatitis A/B/C and HIV).
- Patients with severe comorbidity, for instance, uncontrolled diabetes.
- Patients who concurrently receive potent CYP3A inhibitors.
- Known to have peripheral neuropathy ≥ NCI CTC AE I; but patients who only present loss of deep tendon reflexes (DTRs) may not be excluded;
- Patients with history of organ transplantation who require immunosuppressive therapy;
- Patients who suffer from serious uncontrolled repeated infection, or other serious and uncontrolled disease;
- Moderate or severe renal dysfunction [creatinine clearance ≤ 50ml/min (calculated according to the Cockroft-Gault formula, please refer to Appendix 4）， or serum creatinine > the upper limit of normal (ULN);
- Patients with dihydropyrimidine dehydrogenase (DPD) deficiency;
- Having received any other study drug or agent / treatment (i.e., participated in other trial) within four weeks prior to randomization).
- Other patients considered unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Controlled, Adaptive II/III Study to Compare Neoadjuvant Chemotherapy of Docetaxel, Oxaliplatin, S-1(DOS) Combined With Toripalimab Versus Oxaliplatin, S-1(SOX) Combined With Toripalimab in Locally Advanced Gastric Adenocarcinoma (RESOLVE-2 Study)
This is a randomized, multicenter, controlled, adaptive phase II/III clinical study. The aim is to compare neoadjuvant chemotherapy with docetaxel, oxaliplatin, and S-1 (DOS) plus toripalimab versus oxaliplatin and S-1 (SOX) plus toripalimab in patients with locally advanced gastric adenocarcinoma.
Read the detailed description
This trial is conducted in patients with locally advanced gastric adenocarcinoma. Eligible patients will be randomized in a 1:1 ratio to receive either docetaxel, oxaliplatin, and S-1 (DOS) plus toripalimab for 4 cycles or oxaliplatin and S-1 (SOX) plus toripalimab for 3 cycles as neoadjuvant therapy. Patients who are suitable for surgery will subsequently undergo D2 gastrectomy. Within 8 weeks after surgery, eligible patients will receive postoperative DOS plus toripalimab for 4 cycles or SOX plus toripalimab for 3 cycles, according to their assigned treatment arm. After completion of the combination therapy, toripalimab will be continued every 3 weeks to complete a total duration of 1 year of adjuvant therapy, with a maximum of 17 postoperative cycles of toripalimab. Patients will be followed until death or the study cutoff date determined by the investigators.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Docetaxel+Oxaliplatin+S-1+Toripalimab, Oxaliplatin+S-1+Toripalimab
- Keywords
- gastric adenocarcinoma, neoadjuvant chemotherapy, locally advanced, Oxaliplatin, S-1, Docetaxel, neoadjuvant immunotherapy, toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel+Oxaliplatin+S-1+ToripalimabDrug
Also called Oxaliplatin, S-1, Docetaxel, Toripalimab
Docetaxel 50mg/m2, intravenous drip, D1, combined with Oxaliplatin 85mg/m2, intravenous drip 2h, D1 and S-1 40-60mg bid, orally, D1-7 (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid); Toripalimab, intravenous drip, 3mg/kg, D1 when combined with chemotherapy, or 240mg, D1 as monotherapy; every 14 days for a cycle during combination therapy and every 21 days for a cycle during Toripalimab monotherapy.
Oxaliplatin+S-1+ToripalimabDrug
Also called S-1, Oxaliplatin, Toripalimab
Oxaliplatin 130mg/m2, intravenous drip 2h, D1, combined with S-1 40-60mg bid, orally, D1-14 (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) and Toripalimab 240mg, intravenous drip, D1; every 21 days for a cycle.
| Study group | Role | What they receive |
|---|---|---|
| DOS+Toripalimab | Experimental | Docetaxel+Oxaliplatin+S-1+Toripalimab Receives: Drug: Docetaxel+Oxaliplatin+S-1+Toripalimab |
| SOX+Toripalimab | Active comparator | Oxaliplatin+S-1+Toripalimab Receives: Drug: Oxaliplatin+S-1+Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of pathologic complete response（pCR%）
Evaluation of pCR% of DOS+Toripalimab regimen versus SOX+Toripalimab regimen in locally advanced gastric adenocarcinoma
Measured: 1 year
Secondary outcomes (2)
Progression-free Survival（PFS）
Evaluation of the Progression-free Survival of DOS+Toripalimab regimen versus SOX+Toripalimab regimen in locally advanced gastric adenocarcinoma
Measured: 3 years
Overall Survival（OS）
Evaluation of the Overall Survival of DOS+Toripalimab regimen versus SOX+Toripalimab regimen in locally advanced gastric adenocarcinoma
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start28 Jun 2018
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Jiafu Ji, Professor, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691454
- Sponsor's protocol ID
- CGOG1008
- Acronym
- RESOLVE-2
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2018
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Controlled, Adaptive II/III Study to Compare Neoadjuvant Chemotherapy of Docetaxel, Oxaliplatin, S-1(DOS) Combined With Toripalimab Versus Oxaliplatin, S-1(SOX) Combined With Toripalimab in Locally Advanced Gastric Adenocarcinoma (RESOLVE-2 Study)
- ClinicalTrials.gov ID
- NCT03691454
- Acronym / sponsor ID
- RESOLVE-2 / CGOG1008
- Conditions
- Gastric Adenocarcinoma
- Keywords
- gastric adenocarcinoma, neoadjuvant chemotherapy, locally advanced, Oxaliplatin, S-1, Docetaxel, neoadjuvant immunotherapy, toripalimab
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Oct 2018 (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 randomized, multicenter, controlled, adaptive phase II/III clinical study. The aim is to compare neoadjuvant chemotherapy with docetaxel, oxaliplatin, and S-1 (DOS) plus toripalimab versus oxaliplatin and S-1 (SOX) plus toripalimab in patients with locally advanced gastric adenocarcinoma.
Detailed description
This trial is conducted in patients with locally advanced gastric adenocarcinoma. Eligible patients will be randomized in a 1:1 ratio to receive either docetaxel, oxaliplatin, and S-1 (DOS) plus toripalimab for 4 cycles or oxaliplatin and S-1 (SOX) plus toripalimab for 3 cycles as neoadjuvant therapy. Patients who are suitable for surgery will subsequently undergo D2 gastrectomy. Within 8 weeks after surgery, eligible patients will receive postoperative DOS plus toripalimab for 4 cycles or SOX plus toripalimab for 3 cycles, according to their assigned treatment arm. After completion of the combination therapy, toripalimab will be continued every 3 weeks to complete a total duration of 1 year of adjuvant therapy, with a maximum of 17 postoperative cycles of toripalimab. Patients will be followed until death or the study cutoff date determined by the investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DOS+Toripalimab | Experimental | Drug: Docetaxel+Oxaliplatin+S-1+ToripalimabDocetaxel+Oxaliplatin+S-1+Toripalimab |
| SOX+Toripalimab | Active comparator | Drug: Oxaliplatin+S-1+ToripalimabOxaliplatin+S-1+Toripalimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ambulatory males or females with ages ≥ 18.
- Karnofsky Performance Scale（KPS） ≥ 70.
- Pathologically confirmed gastric adenocarcinoma (including Lauren classification), with a confirmed HER2-negative status (IHC 0, 1+, or 2+ with FISH negative).
- A clinical stage of cIII/IVa (AJCC 8th edition gastric cancer TNM staging) diagnosed by enhanced CT/MRI, combined with endoscopic ultrasound (EUS) and diagnostic laparoscopy if necessary.
- For gastroesophageal junction (GEJ) cancer, only patients with Siewert type III or Siewert type II disease not requiring combined thoracotomy are eligible for enrollment.
Key exclusion criteria (21 listed)
- Pregnancy or lactation women.
- Women of childbearing potential who are positive for the pregnancy test at the baseline or fail to take the test; women after the menopause must have stopped menstruating for at least 12 months that they will be believed to be unable to get pregnant;
- Sexually active (potentially fertile) males and females who are unwilling to take any method of contraception during the study;
- Patients who were previously allergic to monoclonal antibody;
- Patients with active autoimmune diseases;
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 |
|---|---|---|
| Docetaxel+Oxaliplatin+S-1+ToripalimabAlso: Oxaliplatin, S-1, Docetaxel, ToripalimabDocetaxel 50mg/m2, intravenous drip, D1, combined with Oxaliplatin 85mg/m2, intravenous drip 2h, D1 and S-1 40-60mg bid, orally, D1-7 (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid); Toripalimab, intravenous drip, 3mg/kg, D1 when combined with chemotherapy, or 240mg, D1 as monotherapy; every 14 days for a cycle during combination therapy and every 21 days for a cycle during Toripalimab monotherapy. | Drug | DOS+Toripalimab |
| Oxaliplatin+S-1+ToripalimabAlso: S-1, Oxaliplatin, ToripalimabOxaliplatin 130mg/m2, intravenous drip 2h, D1, combined with S-1 40-60mg bid, orally, D1-14 (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) and Toripalimab 240mg, intravenous drip, D1; every 21 days for a cycle. | Drug | SOX+Toripalimab |
Primary outcome
The rate of pathologic complete response（pCR%）
Time frame: 1 year
Evaluation of pCR% of DOS+Toripalimab regimen versus SOX+Toripalimab regimen in locally advanced gastric adenocarcinoma
2 secondary outcomes
Progression-free Survival（PFS）
Time frame: 3 years
Overall Survival（OS）
Time frame: 5 years
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 21 Sep 2026.
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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. This study is not recruiting at the moment.
Jiafu Ji, Professor principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Docetaxel+Oxaliplatin+S-1+Toripalimab and Oxaliplatin+S-1+Toripalimab in people with Gastric Adenocarcinoma, run by Peking University 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 14 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of pathologic complete response（pCR%） (time frame: 1 year). 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 21 Sep 2026.