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NCT04140318
Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma
Phase 2 trial testing sintilimab in Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma in 60 participants. Status unknown.
30 August 2022
Quick facts
| Lead sponsor | Chinese Academy of Medical Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 15 November 2019 |
| Primary completion | 30 August 2022 |
| Estimated completion | 1 February 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- sintilimab — full drug profile →
- nab-paclitaxel (nab-paclitaxel) — full drug profile →
Conditions studied
- Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma — all drugs for Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma →
Sponsor
Chinese Academy of Medical Sciences — full company profile →
Who can join
Adults 18 to 75, any sex, with Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recent Developments of Systemic Chemotherapy for Gastric Cancer.
Arai H, Nakajima TE. · · 2020 · cited 37× · PMID 32354119 · DOI 10.3390/cancers12051100 -
The current management and biomarkers of immunotherapy in advanced gastric cancer.
Chang X, Ge X, Zhang Y, Xue X. · · 2022 · cited 26× · PMID 35623069 · DOI 10.1097/md.0000000000029304 -
Current state of the art: immunotherapy in esophageal cancer and gastroesophageal junction cancer.
Li N, Sohal D. · · 2023 · cited 22× · PMID 37995002 · DOI 10.1007/s00262-023-03566-5 -
Nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) as first-line treatment for advanced biliary tract adenocarcinoma: a phase 2 clinical trial.
Zhang W, Sun Y, Jiang Z, Qu W, et al · · 2023 · cited 9× · PMID 36860259 · DOI 10.21037/hbsn-21-172 -
How to Best Exploit Immunotherapeutics in Advanced Gastric Cancer: Between Biomarkers and Novel Cell-Based Approaches.
Ghidini M, Petrillo A, Botticelli A, Trapani D, et al · · 2021 · cited 9× · PMID 33915839 · DOI 10.3390/jcm10071412 -
Recent advances in the progress of immune checkpoint inhibitors in the treatment of advanced gastric cancer: A review.
Shen J, Wang Z. · · 2022 · cited 8× · PMID 36505771 · DOI 10.3389/fonc.2022.934249 -
Nanotherapeutics Plus Immunotherapy in Oncology: Who Brings What to the Table?
Timon-David E, Perez C, Rodallec A. · · 2022 · cited 2× · PMID 36365144 · DOI 10.3390/pharmaceutics14112326
Verify or expand the search:
- PubMed search for NCT04140318
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of sintilimab
Trials testing the same drug.
- NCT07487662 — TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcin · Phase 2 · not yet recruiting
- NCT07018063 — Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastric Cancer · Phase 2 · not yet recruiting
- NCT07007767 — Exploring Sintilimab + Bevacizumab + Decitabine for Advanced pMMR/MSS Colorectal Cancer (After 2+ Prior Therapies） · Phase 2 · not yet recruiting
- NCT05562297 — Neoadjuvant/Adjuvant Sintilimab, Nab-paclitaxel, and Gemcitabine for Resectable/Borderline Resectable Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT06584032 — Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer · Phase 3 · recruiting
Other Chinese Academy of Medical Sciences trials
Trials by the same sponsor.
- NCT05522894 — AK104 Alone or in Combination With Chemotherapy in the First-line Treatment of ESCC · Phase 2 · unknown
- NCT05499715 — A Phase I Clinical Study to Evaluate the Safety, the Tolerability, the Pharmacokinetic Characteristics and the Efficacy · Phase 1 · unknown
- NCT05484024 — Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer · Phase 2, PHASE3 · not yet recruiting
- NCT05543070 — Low-dose Radiotherapy in iNHL · Phase 2 · unknown
- NCT05460403 — Adjuvant Radiotherapy for Patients With Esophageal Squamous Cell Carcinoma After R0 Resection · unknown
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 NCT04140318 (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 Chinese Academy of Medical Sciences
- Last refreshed: 11 March 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/NCT04140318.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing