Advanced Gastric CancerPhase 4NCT06169410

Ramucirumab Combined With Nab-paclitaxel, Lobaplatin, and S-1 in Neoadjuvant Transformation Therapy for Advanced Gastric Cancer

A Phase 4 study testing nab-paclitaxel, lobaplatin, and S-1 combined with ramucirumab and nab-paclitaxel, lobaplatin, and S-1 in people with Advanced Gastric Cancer, run by Yang Jianjun, PhD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Abstract Objective: Ramucirumab is a VEGFR2 antagonist. The aim of this trial is to evaluate the efficacy and safety of ramucirumab combined with nab-paclitaxel, lobaplatin and S-1 in neoadjuvant and conversion therapy for advanced gastric cancer. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Gastric Cancer
What is being tested?: nab-paclitaxel, lobaplatin, and S-1 combined with ramucirumab and nab-paclitaxel, lobaplatin, and S-1
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteChina
Study dates: 30 Dec 2023to 31 Dec 2025
Phase: Phase 4
Are there results?: None posted in the registry

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

Cohort A: Patients are diagnosed with locally advanced gastric or gastroesophageal junction adenocarcinoma by cytology or histopathology and in need of preoperative neoadjuvant therapy to reduce recurrence and metastasis rates; Cohort B: Patients with advanced gastric cancer who have undergone surgery after neoadjuvant chemotherapy with previously used nab-paclitaxel, lobaplatin and S-1.
Patients are adults aged 18-75 years with an Eastern Cooperative Oncology Group(ECOG) performance status score less than or equals to 1.
Have not received anti-tumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy) .
Functions of the major organs and bone marrow meet the following criteria within 7 days before treatment: hemoglobin ≥ 80g/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet (PLT) ≥ 100× 109/L, without blood transfusion within 14 days, total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5x ULN or if complicated with liver metastasis then ALT and AST ≤ 5x ULN, serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 50mL/min or urinary protein<2+, activated partial thromboplastin time (APTT) and international standardized ratio (INR)≤1.5×ULN.
Expected lifespan ≥ 6 months. The patients are able and willing to provide written informed consent to participate in the study.

Who cannot join

Patients who have previously suffered from other malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
HER-2 positive patients who are willing to receive Herceptin treatment. Women who are pregnant or lactating or in the reproductive period and have not taken effective contraceptive measures, or those who have fertility requirements during the research period.
Patients with serious and uncontrolled internal diseases and infections or with chronic bowel disease or short bowel syndrome.
Patients with major organ failure, such as compensatory heart, lung, liver, and kidney failure as well as severe metabolic abnormalities in liver and kidney which affects normal drug metabolism.
Patients with a clear tendency for gastrointestinal bleeding and/or abnormal coagulation function (INR>1.5)under researchers evaluation.
hepatitis B virus or hepatitis C virus in active phase Patients with peripheral neuropathy neoadjuvant chemotherapy(NCT)-CTCAE ≥ Level 2.
-

Trial locations and contacts

1 site in 1 country.

Jianjun Yang, professor contact

86+029-84771532

yangjj@fmmu.edu.cn

China1 site, 1 recruiting

The First Affiliated Hospital of the Air Force Medical University
Xi'an
Jianjun Yang, 029-84771532, yangjj@fmmu.edu.cn
Recruiting

Other trials in China

About this study

Official title: Evaluation of the Efficacy and Safety of Ramucirumab Combined With Nab-paclitaxel, Lobaplatin, and S-1 in Neoadjuvant and Conversion Therapy for Advanced Gastric Cancer (RNPLS-01)

Methods and analysis: This study is a prospective single-center, randomized controlled and open label clinical study containing two cohorts with 140 patients of advanced gastric cancer (Cohort A n=70; Cohort B n=70). The main efficacy indicator is pathological complete response (pCR) of the cancer after neoadjuvant or conversion therapy. The secondary efficacy indicators are R0 resection rate after neoadjuvant or conversion therapy, the incidence of adverse events (AE), progression-free survival (PFS), overall survival (OS), objective response rate (ORR), total response rate and total response time, disease control rate (DCR) and duration of overall response (DOR).

Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20232220-F-1).

Conditions: Advanced Gastric Cancer
Being tested: nab-paclitaxel, lobaplatin, and S-1 combined with ramucirumab, nab-paclitaxel, lobaplatin, and S-1
Keywords: Ramucirumab, nab-Paclitaxel, lobaplatin, S-1, advanced gastric cancer

What participants receive

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

nab-paclitaxel, lobaplatin, and S-1 combined with ramucirumabDrug
Patients in Experimental group will be given ramucirumab (8mg/kg) by intravenous drip on the first day of each cycle, 3 weeks a cycle.
nab-paclitaxel, lobaplatin, and S-1Drug
Patients will be given lobaplatin (30 mg/m2) and nab-paclitaxel (100mg/m2) by intravenous drip on the first day of each cycle, 3 weeks a cycle, together with oral S-1 (patients with a body surface area less than 1.25 m2, will give 40 mg each time. Patients with a body surface area between 1.25 and 1.5 m2; will give 50 mg each time; patients with a body surface area greater than 1.5 m2, will give 60 mg each time), 2 weeks on and 1 week off.

Study groups in NCT06169410
Study group	Role	What they receive
ramucirumab combined with lobaplatin, S-1 and nab-paclitaxel	Experimental	Patients will be given ramucirumab (8mg/kg), lobaplatin (30 mg/m2) and nab-paclitaxel (100mg/m2) by intravenous drip on the first day of each cycle, 3 weeks a cycle, together with oral S-1 (patients with a body surface area less than 1.25 m2, will give 40 mg each time; patients with a body surface area between 1.25 and 1.5 m2; will give 50 mg each time; patients with a body surface area greater than 1.5 m2, will give 60 mg each time), 2 weeks on and 1 week off. Receives: Drug: nab-paclitaxel, lobaplatin, and S-1 combined with ramucirumab; Drug: nab-paclitaxel, lobaplatin, and S-1
lobaplatin combined with S-1 and nab-paclitaxel	Active comparator	Patients will be given lobaplatin (30 mg/m2) and nab-paclitaxel (100mg/m2) by intravenous drip on the first day of each cycle, 3 weeks a cycle, together with oral S-1 (patients with a body surface area less than 1.25 m2, will give 40 mg each time; patients with a body surface area between 1.25 and 1.5 m2; will give 50 mg each time; patients with a body surface area greater than 1.5 m2, will give 60 mg each time), 2 weeks on and 1 week off. Receives: Drug: nab-paclitaxel, lobaplatin, and S-1

What is being measured

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

pCR
pathological complete response
Measured: 48 months

Secondary outcomes (9)

R0 resection rate
R0 resection rate after neoadjuvant or conversion therapy
Measured: 48 months
AE
the incidence of adverse events (AE)
Measured: 48 months
PFS
progression-free survival (PFS)
Measured: 48 months
OS
overall survival (OS)
Measured: 48 months
ORR
objective response rate (ORR)
Measured: 48 months
total response rate
total response rate
Measured: 48 months
DCR
disease control rate (DCR)
Measured: 48 months
DOR
duration of overall response (DOR)
Measured: 48 months
total response time
total response time
Measured: 48 months

Timeline

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

30 Dec 202331 Dec 2025

First posted13 Dec 2023
Study start30 Dec 2023
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Advanced Gastric CancerStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06169410
Sponsor's protocol ID: RNPLS-01
Status last verified: Jan 2024
First submitted: 19 Nov 2023
Last updated: 23 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Wang J, Wang W, Xu G, Liu S, Jiao L, Wang S, Peng C, Ma Y, Liu X, Huo H, Li H, Li X, Yang J. Efficacy and Safety of ramucirumab Combined With Nab-paclitaxel, Lobaplatin, and S-1 in Conversion Therapy for Unresectable Advanced Gastric Cancer: Preliminary Results of Conversion Therapy Cohort of RNPLS-01 Trial. MedComm (2020). 2026 Nov 3;7(11):e70958. doi: 10.1002/mco2.70958. eCollection 2026 Nov.
PubMed 42984816
Wang J, Xu G, Liu S, Ma Y, Wang S, Li M, Zhao Y, Wang H, Wang Y, Peng C, Huo H, Li H, Ji G, Yang J. Evaluation of the efficacy and safety of ramucirumab combined with nab-paclitaxel, lobaplatin, and S-1 in neoadjuvant and conversion therapy for advanced gastric cancer: A study protocol of prospective single-center, randomized controlled and open label clinical trial (RNPLS-01). Heliyon. 2024 Apr 9;10(8):e29485. doi: 10.1016/j.heliyon.2024.e29485. eCollection 2024 Apr 30.
PubMed 38660276

Want to know more?

Jianjun Yang, professor

86+029-84771532

yangjj@fmmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor

All Advanced Gastric Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy and Safety of Ramucirumab Combined With Nab-paclitaxel, Lobaplatin, and S-1 in Neoadjuvant and Conversion Therapy for Advanced Gastric Cancer (RNPLS-01)
ClinicalTrials.gov ID: NCT06169410
Acronym / sponsor ID: RNPLS-01
Conditions: Advanced Gastric Cancer
Keywords: Ramucirumab, nab-Paclitaxel, lobaplatin, S-1, advanced gastric cancer
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 140 participants (estimated)
Lead sponsor: Yang Jianjun, PhDUniversity, hospital or other
Study start: 30 Dec 2023 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 13 Dec 2023 (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.

Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20232220-F-1).

Study design

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

Arm	Type	Receives
ramucirumab combined with lobaplatin, S-1 and nab-paclitaxel	Experimental	Drug: nab-paclitaxel, lobaplatin, and S-1 combined with ramucirumab, Drug: nab-paclitaxel, lobaplatin, and S-1Patients will be given ramucirumab (8mg/kg), lobaplatin (30 mg/m2) and nab-paclitaxel (100mg/m2) by intravenous drip on the first day of each cycle, 3 weeks a cycle, together with oral S-1 (patients with a body surface area less than 1.25 m2, will give 40 mg each time; patients with a body surface area between 1.25 and 1.5 m2; will give 50 mg each time; patients with a body surface area greater than 1.5 m2, will give 60 mg each time), 2 weeks on and 1 week off.
lobaplatin combined with S-1 and nab-paclitaxel	Active comparator	Drug: nab-paclitaxel, lobaplatin, and S-1Patients will be given lobaplatin (30 mg/m2) and nab-paclitaxel (100mg/m2) by intravenous drip on the first day of each cycle, 3 weeks a cycle, together with oral S-1 (patients with a body surface area less than 1.25 m2, will give 40 mg each time; patients with a body surface area between 1.25 and 1.5 m2; will give 50 mg each time; patients with a body surface area greater than 1.5 m2, will give 60 mg each time), 2 weeks on and 1 week off.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Cohort A: Patients are diagnosed with locally advanced gastric or gastroesophageal junction adenocarcinoma by cytology or histopathology and in need of preoperative neoadjuvant therapy to reduce recurrence and metastasis rates; Cohort B: Patients with advanced gastric cancer who have undergone surgery after neoadjuvant chemotherapy with previously used nab-paclitaxel, lobaplatin and S-1.
Patients are adults aged 18-75 years with an Eastern Cooperative Oncology Group(ECOG) performance status score less than or equals to 1.
Have not received anti-tumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy) .
Functions of the major organs and bone marrow meet the following criteria within 7 days before treatment: hemoglobin ≥ 80g/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet (PLT) ≥ 100× 109/L, without blood transfusion within 14 days, total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5x ULN or if complicated with liver metastasis then ALT and AST ≤ 5x ULN, serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 50mL/min or urinary protein<2+, activated partial thromboplastin time (APTT) and international standardized ratio (INR)≤1.5×ULN.
Expected lifespan ≥ 6 months. The patients are able and willing to provide written informed consent to participate in the study.

Key exclusion criteria (7 listed)

Patients who have previously suffered from other malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
HER-2 positive patients who are willing to receive Herceptin treatment. Women who are pregnant or lactating or in the reproductive period and have not taken effective contraceptive measures, or those who have fertility requirements during the research period.
Patients with serious and uncontrolled internal diseases and infections or with chronic bowel disease or short bowel syndrome.
Patients with major organ failure, such as compensatory heart, lung, liver, and kidney failure as well as severe metabolic abnormalities in liver and kidney which affects normal drug metabolism.
Patients with a clear tendency for gastrointestinal bleeding and/or abnormal coagulation function (INR>1.5)under researchers evaluation.

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
nab-paclitaxel, lobaplatin, and S-1 combined with ramucirumabPatients in Experimental group will be given ramucirumab (8mg/kg) by intravenous drip on the first day of each cycle, 3 weeks a cycle.	Drug	ramucirumab combined with lobaplatin, S-1 and nab-paclitaxel
nab-paclitaxel, lobaplatin, and S-1Patients will be given lobaplatin (30 mg/m2) and nab-paclitaxel (100mg/m2) by intravenous drip on the first day of each cycle, 3 weeks a cycle, together with oral S-1 (patients with a body surface area less than 1.25 m2, will give 40 mg each time. Patients with a body surface area between 1.25 and 1.5 m2; will give 50 mg each time; patients with a body surface area greater than 1.5 m2, will give 60 mg each time), 2 weeks on and 1 week off.	Drug	lobaplatin combined with S-1 and nab-paclitaxel, ramucirumab combined with lobaplatin, S-1 and nab-paclitaxel

Primary outcome

pCR
Time frame: 48 months
pathological complete response

9 secondary outcomes

R0 resection rate
Time frame: 48 months
AE
Time frame: 48 months
PFS
Time frame: 48 months
OS
Time frame: 48 months
ORR
Time frame: 48 months
total response rate
Time frame: 48 months
DCR
Time frame: 48 months
DOR
Time frame: 48 months
total response time
Time frame: 48 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
Derived from this study: PubMed 42984816Wang J, Wang W, Xu G, Liu S, Jiao L, Wang S, Peng C, Ma Y, Liu X, Huo H, Li H, Li X, Yang J. Efficacy and Safety of ramucirumab Combined With Nab-paclitaxel, Lobaplatin, and S-1 in Conversion Therapy for Unresectable Advanced Gastric Cancer: Preliminary Results of Conversion Therapy Cohort of RNPLS-01 Trial. MedComm (2020). 2026 Nov 3;7(11):e70958. doi: 10.1002/mco2.70958. eCollection 2026 Nov.
Derived from this study: PubMed 38660276Wang J, Xu G, Liu S, Ma Y, Wang S, Li M, Zhao Y, Wang H, Wang Y, Peng C, Huo H, Li H, Ji G, Yang J. Evaluation of the efficacy and safety of ramucirumab combined with nab-paclitaxel, lobaplatin, and S-1 in neoadjuvant and conversion therapy for advanced gastric cancer: A study protocol of prospective single-center, randomized controlled and open label clinical trial (RNPLS-01). Heliyon. 2024 Apr 9;10(8):e29485. doi: 10.1016/j.heliyon.2024.e29485. eCollection 2024 Apr 30.
Individual participant dataSharing planned: Undecided

Related trials for Advanced Gastric Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor

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.

Jianjun Yang, professor contact

86+029-84771532

yangjj@fmmu.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jianjun Yang, professor (86+029-84771532, yangjj@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR (time frame: 48 months). 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 NCT06169410, which also lists 2 linked publications.

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 Jan 2024.