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NCT03813784
A Clinical Study To Evaluate Camrelizumab (SHR-1210) Plus Capecitabine and Oxaliplatin Followed by Sequential Treatment With Camrelizumab Plus Apatinib Mesylate in Advanced or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJ) Without Prior Systemic Therapy
Phase 3 trial testing SHR-1210 in Gastric Cancer in 885 participants. Completed in 7 June 2023.
7 June 2023
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 885 |
| Start date | 7 March 2019 |
| Primary completion | 7 June 2023 |
| Estimated completion | 7 June 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- SHR-1210 — full drug profile →
- Capecitabine (capecitabine) — full drug profile →
- Oxaliplatin (Oxaliplatin) — full drug profile →
- Apatinib (Apatinib) — full drug profile →
Conditions studied
- Gastric Cancer — all drugs for Gastric Cancer →
- GastroEsophageal Cancer — all drugs for GastroEsophageal Cancer →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Gastric Cancer or GastroEsophageal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, open-label, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus capecitabine and oxaliplatin sequenced by SHR-1210 plus apatinib versus capecitabine and oxaliplatin as first-line therapy in patients with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2021.
Wang FH, Zhang XT, Li YF, Tang L, et al · · 2021 · cited 502× · PMID 34197702 · DOI 10.1002/cac2.12193 -
Antibodies to watch in 2020.
Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531 -
Targeting cytokine and chemokine signaling pathways for cancer therapy.
Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3 -
The New Era of Immunotherapy in Gastric Cancer.
Takei S, Kawazoe A, Shitara K. · · 2022 · cited 117× · PMID 35205802 · DOI 10.3390/cancers14041054 -
The integration of immune checkpoint inhibitors with VEGF targeted agents in advanced gastric and gastroesophageal adenocarcinoma: a review on the rationale and results of early phase trials.
Saeed A, Park R, Sun W. · · 2021 · cited 74× · PMID 33436042 · DOI 10.1186/s13045-021-01034-0 -
Recent developments in immunotherapy for gastrointestinal tract cancers.
Chong X, Madeti Y, Cai J, Li W, et al · · 2024 · cited 52× · PMID 39123202 · DOI 10.1186/s13045-024-01578-x -
PD-1 blockade synergizes with oxaliplatin-based, but not cisplatin-based, chemotherapy of gastric cancer.
Liu P, Chen J, Zhao L, Hollebecque A, et al · · 2022 · cited 50× · PMID 35769948 · DOI 10.1080/2162402x.2022.2093518 -
Recent Developments of Systemic Chemotherapy for Gastric Cancer.
Arai H, Nakajima TE. · · 2020 · cited 37× · PMID 32354119 · DOI 10.3390/cancers12051100
Verify or expand the search:
- PubMed search for NCT03813784
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SHR-1210
Trials testing the same drug.
- NCT05799183 — A SHR-1210 BE Study on Healthy Subjects · Phase 1 · terminated
- NCT04533490 — A Phase Ⅱ Clinical Trial of Camrelizumab for Adjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma · Phase 2 · unknown
- NCT04680988 — A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer · Phase 2 · completed
- NCT04790539 — a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer · Phase 2 · unknown
- NCT04506242 — Camrelizumab With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer · Phase 2 · unknown
Other recruiting trials for Gastric Cancer
Currently open trials in the same condition.
- NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer · recruiting
- NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers · recruiting
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
- NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · active not recruiting
Other Jiangsu HengRui Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
- NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
- NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
- NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
- NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03813784 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
- Last refreshed: 16 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03813784.
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