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NCT03691090
Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer
Phase 3 trial testing SHR-1210 in Advanced Esophageal Cancer in 596 participants. Completed in 30 April 2022.
30 October 2020
Quick facts
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 596 |
| Start date | 3 December 2018 |
| Primary completion | 30 October 2020 |
| Estimated completion | 30 April 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- SHR-1210 — full drug profile →
- Placebo
- paclitaxel — full drug profile →
- cisplatin (cisplatin) — full drug profile →
Conditions studied
- Advanced Esophageal Cancer — all drugs for Advanced Esophageal Cancer →
Sponsor
Jiangsu HengRui Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Advanced Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial.
Luo H, Lu J, Bai Y, Mao T, et al · · 2021 · cited 592× · PMID 34519801 · DOI 10.1001/jama.2021.12836 -
Antibodies to watch in 2020.
Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531 -
Cold and hot tumors: from molecular mechanisms to targeted therapy.
Wu B, Zhang B, Li B, Wu H, et al · · 2024 · cited 280× · PMID 39420203 · DOI 10.1038/s41392-024-01979-x -
Advances and challenges in the treatment of esophageal cancer.
He S, Xu J, Liu X, Zhen Y. · · 2021 · cited 223× · PMID 34900524 · DOI 10.1016/j.apsb.2021.03.008 -
Understanding Esophageal Cancer: The Challenges and Opportunities for the Next Decade.
Yang J, Liu X, Cao S, Dong X, et al · · 2020 · cited 134× · PMID 33014854 · DOI 10.3389/fonc.2020.01727 -
Current status of treatment with immune checkpoint inhibitors for gastrointestinal, hepatobiliary, and pancreatic cancers.
Eso Y, Seno H. · · 2020 · cited 46× · PMID 32913444 · DOI 10.1177/1756284820948773 -
Combining serum inflammation indexes at baseline and post treatment could predict pathological efficacy to anti‑PD‑1 combined with neoadjuvant chemotherapy in esophageal squamous cell carcinoma.
Zhang X, Gari A, Li M, Chen J, et al · · 2022 · cited 40× · PMID 35109887 · DOI 10.1186/s12967-022-03252-7 -
Comparative genomic analysis of esophageal squamous cell carcinoma and adenocarcinoma: New opportunities towards molecularly targeted therapy.
Zhang X, Wang Y, Meng L. · · 2022 · cited 39× · PMID 35530133 · DOI 10.1016/j.apsb.2021.09.028
Verify or expand the search:
- PubMed search for NCT03691090
- 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 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 NCT03691090 (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: 7 December 2022
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/NCT03691090.
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