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NCT05300269
SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer
Phase 2 trial testing SHR-1701；Capecitabine；Oxaliplatin in Locally Advanced Rectal Cancer in 73 participants. Currently enrolling.
31 July 2024
Quick facts
| Lead sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 5 July 2022 |
| Primary completion | 31 July 2024 |
| Estimated completion | 31 October 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- SHR-1701；Capecitabine；Oxaliplatin — full drug profile →
Conditions studied
- Locally Advanced Rectal Cancer — all drugs for Locally Advanced Rectal Cancer →
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Locally Advanced Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. In all subjects, restaging pelvic MRI with chest and abdominal CT will be performed after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Signaling pathways in cancer-associated fibroblasts: recent advances and future perspectives.
Fang Z, Meng Q, Xu J, Wang W, et al · · 2023 · cited 197× · PMID 36424360 · DOI 10.1002/cac2.12392 -
TGF-beta signal transduction: biology, function and therapy for diseases.
Tie Y, Tang F, Peng D, Zhang Y, et al · · 2022 · cited 97× · PMID 36534225 · DOI 10.1186/s43556-022-00109-9 -
Targeting transforming growth factor beta signaling in metastatic osteosarcoma.
Ge R, Huang GM. · · 2023 · cited 25× · PMID 38021074 · DOI 10.1016/j.jbo.2023.100513 -
The Role of the Transforming Growth Factor-β Signaling Pathway in Gastrointestinal Cancers.
Matsuoka T, Yashiro M. · · 2023 · cited 14× · PMID 37892233 · DOI 10.3390/biom13101551 -
Bispecific Antibodies in Solid Tumors: Advances and Challenges.
Shan KS, Musleh Ud Din S, Dalal S, Gonzalez T, et al · · 2025 · cited 12× · PMID 40565299 · DOI 10.3390/ijms26125838 -
Next-generation immunotherapy for solid tumors: combination immunotherapy with crosstalk blockade of TGFβ and PD-1/PD-L1.
Quach HT, Hou Z, Bellis RY, Saini JK, et al · · 2022 · cited 5× · PMID 36448335 · DOI 10.1080/13543784.2022.2152323 -
Natural Killer Cell-Mediated Antitumor Immunity: Molecular Mechanisms and Clinical Applications.
Luo N, Chen C, Zhou W, Hao J, et al · · 2025 · cited 2× · PMID 40959206 · DOI 10.1002/mco2.70387 -
TGF-β in tumor development and progression: mechanisms and therapeutics.
Liu J, Wang Y, Tang C, Zhang L, et al · · 2026 · cited 1× · PMID 41615651 · DOI 10.1186/s43556-026-00403-w
Verify or expand the search:
- PubMed search for NCT05300269
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07150949 — Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MS · Phase 2 · recruiting
- NCT07057089 — Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I) · Phase 2 · recruiting
- NCT06894797 — Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX in Rectal Cancer. · NA · recruiting
Other Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials
Trials by the same sponsor.
- NCT06844474 — A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC · Phase 2 · recruiting
- NCT06703177 — A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06643754 — A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors · Phase 1, PHASE2 · recruiting
- NCT06618651 — A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors · Phase 1 · recruiting
- NCT06640257 — A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis · Phase 3 · recruiting
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 NCT05300269 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Last refreshed: 29 July 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/NCT05300269.
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