Last reviewed · How we verify
NCT04271813
Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer (APICAL-CRC)
Completed
Phase 2
Last updated 23 April 2024
What this trial tests
Phase 2 trial testing Anlotinib plus Sintilimab in Colorectal Cancer in 30 participants. Completed in 29 February 2024.
Timeline
1 June 2020
Primary endpoint
30 September 2023
30 September 2023
29 February 2024
Quick facts
| Lead sponsor | Shanghai Changzheng Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 June 2020 |
| Primary completion | 30 September 2023 |
| Estimated completion | 29 February 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Anlotinib plus Sintilimab — full drug profile →
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Immunotherapy — all drugs for Immunotherapy →
- Anlotinib — all drugs for Anlotinib →
- Sintilimab — all drugs for Sintilimab →
Sponsor
Shanghai Changzheng Hospital
Who can join
Adults 18 to 75, any sex, with Colorectal Cancer or Immunotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is designed to evaluate the efficacy and safety of the combination of Anlotinib and Sintilimab in advanced colorectal cancer as first-line treatment.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunotherapy efficacy on mismatch repair-deficient colorectal cancer: From bench to bedside.
Lizardo DY, Kuang C, Hao S, Yu J, et al · · 2020 · cited 160× · PMID 33035640 · DOI 10.1016/j.bbcan.2020.188447 -
Immunosuppressive tumor microenvironment modulation by chemotherapies and targeted therapies to enhance immunotherapy effectiveness.
Barnestein R, Galland L, Kalfeist L, Ghiringhelli F, et al · · 2022 · cited 66× · PMID 36117524 · DOI 10.1080/2162402x.2022.2120676 -
Recent updates on Sintilimab in solid tumor immunotherapy.
Liu X, Yi Y. · · 2020 · cited 35× · PMID 33292551 · DOI 10.1186/s40364-020-00250-z -
The Interplay between Anti-Angiogenics and Immunotherapy in Colorectal Cancer.
Maiorano BA, Parisi A, Maiello E, Ciardiello D. · · 2022 · cited 7× · PMID 36294987 · DOI 10.3390/life12101552 -
Potential Immunotherapy Targets for Liver-Directed Therapies, and the Current Scope of Immunotherapeutics for Liver-Related Malignancies.
Charles J, Vrionis A, Mansur A, Mathias T, et al · · 2023 · cited 4× · PMID 37174089 · DOI 10.3390/cancers15092624 -
Anlotinib plus sintilimab as first-line treatment for patients with advanced colorectal cancer (APICAL-CRC): an open-label, single-arm, phase II trial.
Wang Z, Qin BD, Ye CY, Wang MM, et al · · 2025 · cited 1× · PMID 40954146 · DOI 10.1038/s41392-025-02383-9 -
Combination immunotherapy for colorectal cancer: Clinical applications, rationale, challenges, and future perspectives.
Fei J, Cai C, Wu W, Shen H, et al · · 2026 · PMID 41950929 · DOI 10.1016/j.xcrm.2026.102728
Verify or expand the search:
- PubMed search for NCT04271813
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Anlotinib plus Sintilimab
Trials testing the same drug.
- NCT05220267 — Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma · Phase 2 · unknown
Other recruiting trials for Colorectal Cancer
Currently open trials in the same condition.
- NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
- NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
- NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting
Other Shanghai Changzheng Hospital trials
Trials by the same sponsor.
- NCT07527884 — The Effect of Radiotherapy After Separation Surgery for Spinal Metastases · NA · not yet recruiting
- NCT07527728 — Postoperative Neurological Recovery and Risk Factor Analysis in Patients With Paralysis Due to Spinal Metastases · not yet recruiting
- NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
- NCT07398326 — Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer · Phase 2 · recruiting
- NCT07381257 — Efficacy and Safety of Rifaximin-α in Treating MASLD · EARLY_PHASE1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04271813 (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 Shanghai Changzheng Hospital
- Last refreshed: 23 April 2024
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/NCT04271813.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing