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Trial · NCT07385001

A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC

NCT07385001, Phase 1, Phase 2, Recruiting, Tang-Du Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC. Trials, record NCT07385001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07385001

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC
NCT number
NCT07385001
Status
Recruiting
Phases
Phase 1, Phase 2
Enrollment
45 participants, estimated
Lead sponsor
Tang-Du Hospital
Conditions
Esophageal Squamous Cell Carcinoma, Ivonescimab, Neoadjuvant
Interventions
AK112, AK112, AK112 + Neoadjuvant chemotherapy
First posted
2026-02-03
Last updated
2026-02-03

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDLT1 yearDose-limiting toxicity
PrimaryIncidence and Severity of Adverse Events1 year
PrimaryMTD1 yearMaximum tolerated dose
PrimaryRP2D1 yearRecommended Phase II Dose
PrimaryMajor Pathologic Response(MPR)up to 2 yearsDefined as a residual viable tumor percentage (RVT%) ≤ 10%
SecondaryObjective response rate (ORR) by RECIST v1.1Up to 2 yearsORR is defined as the proportion of subjects with confirmed CR or confirmed PR
SecondaryEvent-Free Survival (EFS)Up to 2 yearsEFS is defined as the time from randomization to the occurrence of any event, including disease progression, treatment discontinuation for any reason, or death.
SecondaryTotal survival time (OS)Up to 2 yearsOS defined as the time from the first dose to death from any cause
SecondaryAdverse Events (AE), Serious Adverse Events (SAE), and Immune-Related Adverse Events (irAE): Incidence and SeverityFrom the time of informed consent signed through 90 days after the last dose of study drug

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07385001

GET https://conductscience.org/api/trials/v1/NCT07385001/registered