Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell CarcinomaPhase 2NCT06247956
Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer
A Phase 2 study testing SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection and Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection in people with Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
Objective response rate (ORR) was evaluated to evaluate the efficacy of SHR-8068 combined with adebrelimab and platinum-containing chemotherapy in first-line treatment of advanced gastric and esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma
- What is being tested?
- SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection and Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2024to 30 Dec 2025
- 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
- Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
- Aged 18-75 at the time of signing the informed consent;
- Histologically or cytologically confirmed, unresectable, advanced or recurrent/metastatic adenocarcinoma of the gastric or gastroesophageal junction, or unresectable or recurrent/metastatic esophageal squamous cell carcinoma without radical chemoradiation;
- At least one measurable lesion consistent with RECIST v1.1;
- ECOG PS score: 0-1;
- The organ function level is good;
Who cannot join
- Her2-positive patients;
- Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
- Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
- Previous or co-existing malignant neoplasms;
- The presence of any active or known autoimmune disease;
- People who have previously received an organ transplant;
- Have clinical symptoms or diseases of the heart that are not well controlled;
- Known allergic reactions to adebrelimab or other monoclonal antibodies or investigational drugs;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open, Multicenter Phase II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the First-line Treatment of Advanced Gastric and Esophageal Cancer
Objective response rate (ORR) was evaluated to evaluate the efficacy of SHR-8068 combined with adebrelimab and platinum-containing chemotherapy in first-line treatment of advanced gastric and esophageal cancer.
- Being tested
- SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection, Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin InjectionDrug
SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Oxaliplatin: Specified dose on specified days. Capecitabine Tablets: Specified dose on specified days. Paclitaxel Injection: Specified dose on specified days. Cisplatin Injection: Specified dose on specified days.
Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin InjectionDrug
Adebrelimab: Specified dose on specified days. Oxaliplatin Injection: Specified dose on specified days. Capecitabine Tablets: Specified dose on specified days. Paclitaxel Injection: Specified dose on specified days. Cisplatin Injection: Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| SHR-8068 combined with adebrelimab and platinum-containing chemotherapy | Experimental | Not described Receives: Drug: SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection |
| Adebrelimab combined with platinum-containing chemotherapy | Active comparator | Not described Receives: Drug: Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR based on RECIST v1.1 assessment.
Measured: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years
Secondary outcomes (1)
DCR based on RECIST v1.1 assessment
Measured: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start11 Mar 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247956
- Sponsor's protocol ID
- SHR-8068-201-GC
- Status last verified
- Aug 2025
- First submitted
- 30 Jan 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Multicenter Phase II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the First-line Treatment of Advanced Gastric and Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06247956
- Acronym / sponsor ID
- SHR-8068-201-GC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Feb 2024 (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.
Objective response rate (ORR) was evaluated to evaluate the efficacy of SHR-8068 combined with adebrelimab and platinum-containing chemotherapy in first-line treatment of advanced gastric and esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-8068 combined with adebrelimab and platinum-containing chemotherapy | Experimental | Drug: SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection |
| Adebrelimab combined with platinum-containing chemotherapy | Active comparator | Drug: Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
- Aged 18-75 at the time of signing the informed consent;
- Histologically or cytologically confirmed, unresectable, advanced or recurrent/metastatic adenocarcinoma of the gastric or gastroesophageal junction, or unresectable or recurrent/metastatic esophageal squamous cell carcinoma without radical chemoradiation;
- At least one measurable lesion consistent with RECIST v1.1;
- ECOG PS score: 0-1;
Key exclusion criteria (8 listed)
- Her2-positive patients;
- Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
- Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
- Previous or co-existing malignant neoplasms;
- The presence of any active or known autoimmune disease;
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 |
|---|---|---|
| SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin InjectionSHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Oxaliplatin: Specified dose on specified days. Capecitabine Tablets: Specified dose on specified days. Paclitaxel Injection: Specified dose on specified days. Cisplatin Injection: Specified dose on specified days. | Drug | SHR-8068 combined with adebrelimab and platinum-containing chemotherapy |
| Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin InjectionAdebrelimab: Specified dose on specified days. Oxaliplatin Injection: Specified dose on specified days. Capecitabine Tablets: Specified dose on specified days. Paclitaxel Injection: Specified dose on specified days. Cisplatin Injection: Specified dose on specified days. | Drug | Adebrelimab combined with platinum-containing chemotherapy |
Primary outcome
ORR based on RECIST v1.1 assessment.
Time frame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years
1 secondary outcome
DCR based on RECIST v1.1 assessment
Time frame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 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 3 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection and Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection in people with Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. 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 8 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 3 Sep 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?
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?
ORR based on RECIST v1.1 assessment. (time frame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years). 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 3 Sep 2025.