Gastric and Gastroesophageal Junction (GEJ) AdenocarcinomaPhase 2NCT07026149
Perioperative Treatment of Combined Radiotherapy With SOX, Apatinib and Camrelizumab for Oesophagogastric Cancer
A Phase 2 study testing Apatinib+Camrelizumab+SOX and Preoperative Radiotherapy in people with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, safety and tolerability of radiotherapy and chemotherapy, apatinib with camrelizumab in the neoadjuvant (prior to surgery) and adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
- What is being tested?
- Apatinib+Camrelizumab+SOX and Preoperative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2025to 31 May 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
- Plans to proceed to surgery following pre-operative chemotherapy. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Has adequate organ function.
- Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
- Has life expectancy of greater than 12 months.
Who cannot join
- Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
- Known hypersensitivity to any of the study drugs or excipients.
- Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
- Congenital or acquired immune deficiency (e.g. HIV infected)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Shu-Bei Wang, MD, +86-021-64370045 ext. 602400, wangshubei@163.com
About this study
Official title: Perioperative Treatment of Combined Radiotherapy With SOX, Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Phase II Trial
The study is being conducted to evaluate the efficacy, safety and tolerability of radiotherapy and chemotherapy, apatinib with camrelizumab in the neoadjuvant (prior to surgery) and adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
- Being tested
- Apatinib+Camrelizumab+SOX, Preoperative Radiotherapy
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib+Camrelizumab+SOXDrug
Apatinib 250mg+Camrelizumab 200mg +S-1, Oxaliplatin, q3w
Preoperative RadiotherapyRadiation
Radiotherapy was administered using IMPT or IMRT. The target volume includes the gastric lesion, and regional lymph nodes. A regimen of 41.4 Gy in 23 fractions is preferred.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Radiotherapy and Apatinib and Camrelizumab and S-1 and Oxaliplatin Receives: Drug: Apatinib+Camrelizumab+SOX; Radiation: Preoperative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response
Measured: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Secondary outcomes (8)
Total Pathological Complete Response (tpCR)
Measured: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Major pathological response(MPR)
Measured: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Margin-free (R0) resection rate
Measured: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Lymph node status after neoadjuvant therapy (ypN staging)
Measured: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
DFS
Measured: up to 2 years
OS
Measured: up to 2 years
Local control rate
Measured: up to 2 years
AEs
Measured: Up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start8 Jun 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric and Gastroesophageal Junction (GEJ) AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026149
- Sponsor's protocol ID
- 2024373
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li C, Tian Y, Zheng Y, Yuan F, Shi Z, Yang L, Chen H, Jiang L, Wang X, Zhao P, Zhang B, Wang Z, Zhao Q, Dong J, Lian C, Xu S, Zhang A, Zheng Z, Wang K, Dang C, Wu D, Chen J, Xue Y, Liang B, Cheng X, Wang Q, Chen L, Xia T, Liu H, Xu D, Zhuang J, Wu T, Zhao X, Wu W, Wang H, Peng J, Hou Z, Zheng R, Chen Y, Yin K, Zhu Z. Pathologic Response of Phase III Study: Perioperative Camrelizumab Plus Rivoceranib and Chemotherapy Versus Chemotherapy for Locally Advanced Gastric Cancer (DRAGON IV/CAP 05). J Clin Oncol. 2025 Feb;43(4):464-474. doi: 10.1200/JCO.24.00795. Epub 2024 Oct 9.
PubMed 39383487
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Treatment of Combined Radiotherapy With SOX, Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Phase II Trial
- ClinicalTrials.gov ID
- NCT07026149
- Acronym / sponsor ID
- 2024373
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 8 Jun 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 18 Jun 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.
The study is being conducted to evaluate the efficacy, safety and tolerability of radiotherapy and chemotherapy, apatinib with camrelizumab in the neoadjuvant (prior to surgery) and adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Apatinib+Camrelizumab+SOX, Radiation: Preoperative RadiotherapyRadiotherapy and Apatinib and Camrelizumab and S-1 and Oxaliplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
- Plans to proceed to surgery following pre-operative chemotherapy. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Has adequate organ function.
- Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
Key exclusion criteria (4 listed)
- Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
- Known hypersensitivity to any of the study drugs or excipients.
- Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
- Congenital or acquired immune deficiency (e.g. HIV infected)
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 |
|---|---|---|
| Apatinib+Camrelizumab+SOXApatinib 250mg+Camrelizumab 200mg +S-1, Oxaliplatin, q3w | Drug | Arm 1 |
| Preoperative RadiotherapyRadiotherapy was administered using IMPT or IMRT. The target volume includes the gastric lesion, and regional lymph nodes. A regimen of 41.4 Gy in 23 fractions is preferred. | Radiation | Arm 1 |
Primary outcome
Pathological Complete Response
Time frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
8 secondary outcomes
Total Pathological Complete Response (tpCR)
Time frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Major pathological response(MPR)
Time frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Margin-free (R0) resection rate
Time frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
Lymph node status after neoadjuvant therapy (ypN staging)
Time frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment
DFS
Time frame: up to 2 years
OS
Time frame: up to 2 years
Local control rate
Time frame: up to 2 years
AEs
Time frame: Up to approximately 18 months
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 18 Jun 2025.
- Results publication: PubMed 39383487Li C, Tian Y, Zheng Y, Yuan F, Shi Z, Yang L, Chen H, Jiang L, Wang X, Zhao P, Zhang B, Wang Z, Zhao Q, Dong J, Lian C, Xu S, Zhang A, Zheng Z, Wang K, Dang C, Wu D, Chen J, Xue Y, Liang B, Cheng X, Wang Q, Chen L, Xia T, Liu H, Xu D, Zhuang J, Wu T, Zhao X, Wu W, Wang H, Peng J, Hou Z, Zheng R, Chen Y, Yin K, Zhu Z. Pathologic Response of Phase III Study: Perioperative Camrelizumab Plus Rivoceranib and Chemotherapy Versus Chemotherapy for Locally Advanced Gastric Cancer (DRAGON IV/CAP 05). J Clin Oncol. 2025 Feb;43(4):464-474. doi: 10.1200/JCO.24.00795. Epub 2024 Oct 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib+Camrelizumab+SOX and Preoperative Radiotherapy in people with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Ruijin Hospital 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 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 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-Bei Wang, MD (+86-021-64370045 ext. 602400, wangshubei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (time frame: Up to 6 weeks after completion of radiotherapy and 3 cycles (each cycle is 21 days) of neoadjuvant drug treatment). 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 NCT07026149, which also lists 1 linked publication.
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 18 Jun 2025.