Drug

Sintilimab

In clinical development

ClassProgrammed cell death protein 1 antagonistEmerging researchLate-stage development

Also known as Sindilizumab, Sindillimab.

RxNorm2214430 ChEMBLCHEMBL4297829UNII8FU7FQ8UPK

Research papers

Active clinical trials

Programmed cell death protein 1

Primary target

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial

Clinical trial2026-07-07Results expected Q1 2030 · ClinicalTrials.gov

Trifluridine and Tipiracil Hydrochloride Tablets, Bevacizumab and Sintilimab With/Without Involved Lesions Irradiation as 3rd- or Later-line Therapy for Advanced MSS/pMMR Colorectal Cancer: a Phase 2, Double Cohort Clinical Trial

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Single-Arm, Open-Label, Exploratory Phase II Clinical Trial of Sintilimab Plus Gossypol Acetate in Patients With Advanced pMMR/MSS Colorectal Cancer After Failure of at Least Two Prior Lines of Therapy

Clinical trial2026-06-25Results expected Q3 2027 · ClinicalTrials.gov

Intensified Adjuvant Therapy for High-Risk Newly Diagnosed Glioblastoma With Subtotal Resection or Short-Term Progression: A Prospective, Single-Arm Phase II Clinical Study

Clinical trial2026-06-25Results expected Q4 2027 · ClinicalTrials.gov

A Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

Clinical trial2026-06-11Results expected Q4 2031 · ClinicalTrials.gov

A Single-Arm, Prospective, Multicenter Study of Ipilimumab (N01) Plus Sintilimab and Modified XELOX as Conversion Therapy in Unresectable Locally Advanced Gastric Cancer

Clinical trial2026-06-10Results expected Q4 2028 · ClinicalTrials.gov

A Phase Ib/II Study of AK112 in Combination Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

A Single-Center, Phase II Clinical Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin Neoadjuvant Therapy in Triple-Negative Breast Cancer.

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Efficacy and Safety Trial of XH001 (Neoantigen Cancer Vaccine) Sequential Combination With Immunocheckpoint Inhibitor and Chemotherapy in Adjuvant Therapy for Patients With Resected Pancreatic Cancer

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

IBI343 Combined With Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Dragon15)

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4).

Research2021-10-27Signal transduction and targeted therapy

Neoadjuvant PD-1 inhibitor (Sintilimab) in NSCLC.

Research2020-02-06Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Sintilimab

Aliases & brands

SindilizumabSindillimab

RxNorm CUI

2214430

ChEMBL ID

CHEMBL4297829

UNII

8FU7FQ8UPK

Primary mechanism

Programmed cell death protein 1 antagonist

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Programmed cell death protein 1

PDCD1 · Q15116

ANTAGONISTProgrammed cell death protein 1 antagonist

Clinical trials

197 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

197

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 197

Early Phase 12Phase 122Phase 1 / 212Phase 2133Phase 2 / 34Phase 314Phase 41Phase N / A9

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Real-world Study of Brentuximab Vedotin Monotherapy and Combination Regimens in the Treatment of Relapsed/Refractory Hodgkin Lymphoma

Not yet recruitingPH IVXiuhua Sunn=1002026

Not yet recruitingPH IIIGuangdong Provincial People's Hospitaln=1482035

Not yet recruitingPH II/IIIInnovent Biopharmaceutical Technology (Hangzhou) Co., LTD.n=7202031

Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2101)

RecruitingPH IIISun Yat-sen Universityn=4222031

Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE Ⅱ）：A Prospective, Randomized, Open-Label, Multi-Center Phase 3 Trial

RecruitingPH IIISecond Affiliated Hospital, School of Medicine, Zhejiang Universityn=2502029

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open-label Phase II Trial Evaluating the Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in Early-stage Triple-negative Breast Cancer（NeoSACT）

CompletedPH IIGuangdong Provincial People's Hospitaln=292026

A Phase 2 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab for Advanced Rare Cancers (SiARa Cancer Study) - Cancer of Unknown Primary (SiARa-CUP)

CompletedPH IIM.D. Anderson Cancer Centern=102025

A Phase II Study of Transcatheter Arterial Chemoembolization (TACE) Combined with Anti-PD-1 Antibody （IBI308） in Patients with Advanced Hepatocellular Carcinoma

CompletedPH IIFudan Universityn=252025

Sintilimab Plus Bevacizumab in Patients With Recurrent/Persistent Ovarian Clear Cell Carcinoma

CompletedPH IITongji Hospitaln=382024

A Phase I/II Dose-Escalation and Efficacy/Safety Study of Afuresertib Plus Sintilimab Plus Chemotherapy in Patients With Selected Solid Tumors That Resistance to Prior Anti-PD-1/PD-L1 Treatment

CompletedPH I/IILaekna Limitedn=222024

A Phase II Study of Transcatheter Arterial Chemoembolization (TACE) Combined with Sintilimab Plus Bevacizumab Biosimilar in Patients with Advanced Hepatocellular Carcinoma (TASK-02)

CompletedPH IIFudan Universityn=292024

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20202021

Most influential

Neoadjuvant PD-1 inhibitor (Sintilimab) in NSCLC.

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2020 · 321 cites

Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4).

Signal transduction and targeted therapy · 2021 · 90 cites