Cadonilimab+ Paclitaxel (Albumin-bound) Treat Advanced Gastric Adenocarcinoma With PD-(L)1 Inhibitors Resistance

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChina Medical University, China

About this trial

Cadonilimab combined with paclitaxel (albumin-bound) treat advanced gastric adenocarcinoma or esophagogastric junction adenocarcinoma with PD-(L)1 inhibitors resistance

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be able to understand and voluntarily sign a written informed consent, which must be signed prior to performing the specified study procedure required for the study.

Age and gender: ≥18 years old and≤75 years old, both men and women.

The Eastern United States Cancer Collaborative (ECOG) physical Fitness score was 0-1.

Histologically or cytologically confirmed unresectable or metastatic gastric adenocarcinoma or esophagogastric junction adenocarcinoma (EGJ defined as the center of the tumor within 5 cm of the anatomic location of the cardia, as described in the Siewert classification system).

Disqualifiers

Other pathological types confirmed by histopathological or cytological examination, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma and Mixed pathological types will be judged according to the main components, adenocarcinoma components confirmed by the pathologist greater than 70% can be included in the group

Participants had other malignancies within 3 years prior to enrollment. Subjects with other malignancies that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical cancer, or carcinoma in situ of the breast, are not excluded.

The last systemic anti-tumor therapy, including chemotherapy and radiotherapy, immunotherapy, targeted therapy (small molecule targeted therapy is within 2 weeks before the first drug administration), and biologic therapy, was received within 3 weeks before the first drug administration; Palliative local treatment for non-target diseases and foci was performed within 2 weeks before the first administration; Received systemic non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, etc.) within 2 weeks prior to initial administration; Received Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications within 2 weeks prior to the first administration。

Previously received immunotherapy other than PD-1/PD-L1 inhibitors, including immune checkpoint inhibitors (such as anti-CTLA-4 antibodies, anti-CD47 antibodies, anti-SIRP-α antibodies, anti-LAG-3 antibodies, etc.), immune checkpoint agonists, and immune cell therapy Any treatment targeting the immune mechanism of tumor action.

Trial design

Design model

Single group

Treatments tested in this trial

  • cadonilimab combined +paclitaxel (albumin-bound)

    Drug

    1. In the safe induction phase6 subjects will receive cadonilimab (10mg/kg, Q3W, intravenous infusion, up to 2 years) and paclitaxel (albumin-bound type)(125 mg/m2,Days1, 8,Q3w, intravenous infusion, up to 8 cycles). 2. If the safety and tolerability are good, and the initial efficacy signal is observed, the extended enrollment phase will enter the extended enrollment phase of drug administration and the safety introduction phase

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: cadonilimab combined +paclitaxel (albumin-bound)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-month progression-free survival assessed by RECIST v1.1

6-month progression-free survival assessed by RECIST v1.1

Time frame
6-month

Secondary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR)

Time frame
Until the investigator determines that there is no longer a clinical benefit , toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco
2

disease control rate (DCR)

disease control rate (DCR)

Time frame
Until the investigator determines that there is no longer a clinical benefit , toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco
3

duration of response (DoR)

duration of response (DoR)

Time frame
Until the investigator determines that there is no longer a clinical benefit , toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco
4

progression-free survival (PFS)

progression-free survival (PFS)

Time frame
Until the investigator determines that there is no longer a clinical benefit , toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco

Other outcomes

1

PD-L1 expression

PD-L1 expression

Time frame
Until the investigator determines that there is no longer a clinical benefit , toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco
2

MMR status

MMR status

Time frame
Until the investigator determines that there is no longer a clinical benefit , toxicity is intolerable, treatment is completed at 24 months, or other protocol criteria for disco

Locations

This trial has no locations.

Sponsors and contacts

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